Briefing for Joint Cabinet Committee on Health & Children.
19th July 2012.
Voluntary recall of DePuy ASR Hip Resurfacing System and ASR XL Acetabular System
Background
DePuy Orthopaedics, Inc. announced on 24th August 2010 that it had commenced a voluntary
worldwide recall process for two specific hip replacement implant products. Approximately 3,317
patients had received these implants in Ireland, across 16 public and 14 private hospital sites. The
HSE became aware of the recall on 26th August. Worldwide approximately 93,000 components were
implanted, affecting 54,000 patients. 36,000 of those devices were sold in the USA, 14,000 in the UK
and 4,756 in Ireland
Governance
An Incident Management Team (IMT) was established to oversee the national recall of patients in
both public and private sites in Ireland. Membership includes the Irish Institute of Trauma and
Orthopaedic Surgery (IITOS), the Independent Hospitals Association of Ireland (IHAI), representing
private hospitals, a Patient Representative and representative of HSE Legal Services, Finance, ICT and
Procurement Directorates. Shared guidelines and procedures were issued. The IMT was
responsible for interaction with DePuy and working through the logistics involved, in line with the
company’s commitment to covering the costs of the recall process for patients and any medical
treatment that patients may need.
Process of recall
Sites were required to identify, as a matter of urgency, all affected patients. Telephone Help-Lines
were established to deal with enquiries from members of the public, and to provide information to
patients. Using data supplied by the products distributors, sites commenced a process of identifying
all affected patients, by matching/reconciling component product numbers, theatre logs etc.
Priority was given to ensuring that all affected patients were identified and notified, whilst also
ensuring that patients who had not received the affected components were advised and reassured.
Affected patients were contacted to attend for a recall assessment appointment and possible
treatment. It was expected that for most patients involved, the recall would be precautionary, but
for those who would require further treatment, it would be provided to them without cost to the
patient.
The IMT prescribed a phased approach to the recall.
Phase 1 referred to an initial recall for all patients; clinical examination, blood and radiological tests
as required.
Phase 2 referred to a smaller number of patients requiring follow up treatment or revision surgery.
The IMT compiled a detailed Incident Management Procedure Document for Phase One – giving
hospital sites instructions on all the steps required to ensure an effective and patient/centered recall
process. This included – identification/validation for affected patients, clinical protocols and
pathways (Clinical, Radiology, Blood testing), communication with patients, and reporting
requirements. This set of procedures issued to hospital sites on October 1st, 2010, with a number of
subsequent iterations, incorporating updates as they became available.
Given that the recall encompassed 30 sites, some with a large proportion of the total number of
patients, the timing of both the both the invitations to appointments and the scheduled
appointment dates varied from site to site. However, a target date of identifying and contacting
patients was set for Oct 20th 2010. The majority of sites had identified affected patients by early Nov
2010, with all patients identified and contacted by late Nov 2010. Scheduling of initial appointments
commenced immediately, with recall clinics commencing in October 2010. For those sites that had
smaller numbers of patients, patient’s appointments were scheduled relatively quickly. For larger
sites, the numbers of patients posed some logistical problems in scheduling clinics; the approach
taken was to schedule patients based on clinical need/urgency.
Clinical Matters
As part of the clinical protocols provided for the testing of blood for metal ion levels (cobalt and
chromium), a streamlined process for phlebotomy, transportation and testing blood samples for
metal ion levels was established. Laboratory selection was based on assessment by a HSE Chemical
Pathologist and member of the clinical subgroup of the IMT. l. Samples are transported to the
accredited Laboratory in London for independent testing of blood samples for cobalt and chromium
levels. Samples are transported from individual sites to the laboratory by a specialized shipping
company. De Puy funds this process directly, with no cost to the individual sites.
The majority of patients did not require revision surgery and have been scheduled for annual review.
They are currently attending year two appointments.
A smaller number, for whom revision surgery was not an immediate requirement, but did require
closer monitoring, were scheduled for six monthly review.
Three hundred and fifty seven revision surgeries have been carried out to date and with a further
166 revisions scheduled. Given the nature of hip replacement follow-up, revisions will continue to
be carried out over the coming years, based on individual clinical need.
Interaction between the IMT and De Puy:
De Puy stated that they intended to cover ‘reasonable and customary costs’ of monitoring and
treatment for services, associated with the recall, including revision surgeries
At the commencement of the recall the IMT had concerns regarding the process in place for contact
with De Puy and the company’s ability to make rapid/significant enabling decision relating to the
recall. Considerable effort was required to identify designated De Puy personnel with appropriate
decision-making delegation to authorize required/necessary steps in the recall. In November 2010,
the De Puy employed an n ASR Regulatory contact for Ireland and he continues to be the point of
contact for interaction between the HSE/De Puy.
Non medical Patient expenses:
Whilst De Puy committed to covering the costs associated with the medical care of the affected
patients, there was also the issue of non-medical, ‘out of pocket’ expenses incurred by patients e.g.
travel to medical appointments, possible overnight accommodations, leave from work costs etc. De
Puy appointed Thorntons Ltd (a subsidiary of UK Claims Handling Company, Crawford Broadspire),
to handle the reimbursement of claims for expenses, both to Hospitals and to patients. Whilst the
reimbursement of non-medical costs was not the responsibility of the HSE or private healthcare
organizations, it was recognized that this aspect of the patient experience could potentially be a
source of difficulty/inconvenience for patients. Patients were issued with a ‘Unique identifier
number’ which would allow them to contact and claim directly from the claims handling company
for any out of pocket expenses incurred.
Legal Matters
From the commencement of the voluntary recall, it was evident that a number of law firms were
seeking clients for potential legal action in relation to future revisions, actions in which the hospital
or the HSE would likely be defendants/co-defendants.
The IMT, at the encouragement of the Patient Representative on the team, and with the strong
agreement of the HSE in-house barrister, sought to establish a mediation scheme, which would
involve establishing a non-adversarial process for patients, to facilitate settlement of both the
straightforward and more complex claims that would arise from the recall. The Clinical Indemnity
Scheme (CIS) offered to assist with this process. De Puy did not avail of this offer. The IMT does not
have ongoing involvement in legal aspects of the recall and refers these to the State Claims Agency.
The State Claims Agency, which is tasked with protecting the States interest, is currently preparing to
defend those claims naming the HSE. In June 2012 approximately 100 claims were
instigated/intimated.
The State Claims Agency and the HSE legal representatives continue to address any issues that arise
in the context of dealing with proceedings notified and establishing any necessary processes to
ensure these are addressed.
A range of other issues have been resolved between the IMT and DePuy, after an extended period of
negotiation and joint working.
Patient Consent
At the commencement of the recall, and in line with their international policy, De Pay required that
patients would consent to De Puy accessing various information /medical records without
restriction. This was not acceptable to with the HSE or private sites on legal, data protection and
patient privacy grounds. During 2010, De Pay had only agreed to reimburse costs arising for phase 1
of the recall i.e. clinical examination, blood tests, and X Rays, De Puy stated that agreement on
reimbursement of Phase 2 costs, having waited the requirement to access medical notes for phase
one, would certainly be conditional on access to patient medical records
Following a protracted series of negotiations between the IMT and De Puy, De Puy agreed to fund
reimbursement of medical costs based on verification/ certification by the treating Consultant that
the medical costs were appropriately and validly incurred as a result of the recall. (Surgeons would
complete a surgeon confirmation form - DPYUS 73) This agreement was reached in Feb 2011,
following escalation of the matter to senior personnel within De Puy.
Reimbursement
A Finance/Procurement subgroup of the Incident Management Team liaised with De Puy on the
reimbursement process for all direct and indirect recall associated costs incurred by the HSE sites,
and an agreed protocol for processing claims.
A Tariff method of reimbursement was agreed for each clinical stage was agreed with De Puy in
October 2011, and enabled reimbursement of HSE hospitals by DePuy for the costs of recall
appointments, tests, treatment and surgery, via submission of validated claims to the Claims
handling company. A similar reimbursement process was adopted by private Healthcare providers,
based on private insurer rates. Any claims for expenses not covered by the Tariff are submitted to
the De Puy Exceptions Committee for adjudication on a case by case basis. Reimbursement is
subject to certain exclusions as outlined by De Puy e.g. Size Mismatches, Traumatic injury where there is no evidence of soft tissue reaction at the time
of surgery, femoral neck fractures where the fracture occurred within three months of primary
surgery and subject to review on a case by case basis, or infection confirmed through positive
culture.
Explant Management
Decontamination of explanted (removed) components posed some operational and regulatory
difficulties which required clinical and legal expertise; in particular the issues of custody of the
explant and decontamination of explants.
Initially DePuy requested access to explants and agreed to fund decontamination and storage on
that basis. They later changed that position and determined that they did not want access to
explants under any circumstances. Subsequently the Irish Medicines Board outlined that since the
products had been recalled, they required DePuy to undertake investigations into the reason for the
device failure as part of the IMB statutory role in regulating medical devices.
In Aug 2010, Patients were initially given three options prior to undergoing revision surgery, via
written consent:
1. Send the implant to DePuy for product failure investigation ( process funded by DePuy in
order to discharge its requirement to provide inspection reports to the IMB)
2. Hospital Disposal: The HSE or private hospitals can dispose of the device once it is removed.
3. Patient Custody: Where patients wish to retain the implant themselves, they will be
required to arrange the decontamination, transport and storage of the implant, at their own
expense.
Legal advice was received from HSE legal advisors to confirm these options were reasonable.
Subsequently, patients’ legal representatives sought clarification on a number of issues, including
those of - informed consent, access to explants upon request, provision of inspection reports etc. An
updated suite of consent documentation was drafted by the HSE Legal advisors, in conjunction with
De Puy legal representatives and patient legal representatives to reflect the following – (and issued
by the IMT in Oct 2011)  Ownership and control of explants at all times rest with the patient,
 Where the patient consented to forwarding their explant to London Implant Retrieval
Centre, De Puy would not take possession of the explant.
 Inspection reports would be furnished by the LIRC upon request to the patient/legal
representative, De Puy, Irish Medicines Board.
 The explant could be returned to the patient at a future date.
As the explants were not reusable implantable medical devices, the normal decontamination
protocols did not apply. Usually such devices would be disposed of upon removal. However, the
issue of retention of such explants for possible evidentiary purposes in any future litigation arose.
Advice from the Irish Medicines Board was that in such cases, decontamination of devices would be
in accordance with the manufacturer’s protocol. Difficulties arose in that the majority of sites in the
HSE/Private Healthcare providers did not have the required facilities to enable decontamination
according to the De Puy protocol. Where patients chose to send the explant to De Puy under the De
Puy funded retrieval process, the accredited implant retrieval facility undertakes this
decontamination process in accordance with the relevant manufacturer’s protocols, which have
been applied by court order in the United States.
With regard to those patients who choose to retain their implant, the HSE has engaged with the
implant retrieval facility (who are providing the service on behalf of De Puy) , to facilitate a separate
process to arrange for the decontamination/inspection/storage of the explants separately for those
patients who do not consent to De Puy accessing their explants.
In early 2012 it became evident that a number of patient/legal representatives were instructing sites
to forward their explants to storage facilities, who did not offer decontamination/inspection
services. Sites were being instructed by patients/legal representatives to release such explants The
HSE sought the IMB advice on this matter, particularly with regard requirements regarding
transportation of bio hazardous material. The IMB referred the HSE to the Dept of the Environment.
The Dept of the Environment advised that it was satisfied with the HSE proposed position of
releasing such explants upon receipt of assurance that the carrier /packaging complied with relevant
sections of ADR Regulations regarding transport of bio hazardous material.
Private Health Insurers –
A number of private Health insurance companies contacted the HSE seeking details of privately
insured patients who had been identified as having received the ASR implants. Private Hospitals
were obliged as part of their contract to provide such information. The HSE position initially was
that data protection legislation placed certain obligations on the organisation regarding the
transmission of patient information to third parties. Subsequently legal advice was that the patient
authorisation, which the patients signs on private insurance claim forms, is sufficient to cover, on a
retrospective basis, the required information. Sites are now providing the following information to
Private Insurers;
Patient Name, Insurance Policy Number. Date of admission/Discharge, Claim number.
Protocol for reimbursement of treating/monitoring costs into the future
The HSE became aware early in 2012 that De Puy intended to reimburse costs incurred on the
following basis - which was their current worldwide policy
 Non revised patients - 5 years monitoring costs covered
 Revised patients - 6 months of monitoring and treating of any related
complications, and 12 weeks post rehab.
 Outside of this, approval on a case by base basis by the De Puy Exceptions Review Panel.
The HSE position was outlined to De Puy - requiring De Puy to commit to funding costs of
monitoring/treating patients on an ongoing basis as costs are incurred – this position was relayed to
the De Puy Vice President, Medical Affairs, at a meeting in Feb 2012. De Puy have advised that they
were currently evaluating the reimbursement time frame, but that it would be later in 2012 before
they could advise of their position with regard to this.
The HSE was notified in July 12 that De Puy had effectively lifted the time limits for reimbursement
and had agreed to ongoing funding Under De Puys new reimbursement guidelines there is no time
restriction for reimbursement and each patient will be dealt with on a case by case basis.
Patient Information
A number of queries are arising from patients with co-existing complex medical /surgical conditions,
who will require more complex medical support and these are being addressed as they arise, in
conjunction with De Puy, on an individual case basis.
In July 2011 a public meeting in the South East had been organised by a patient representative
group. The HSE was represented by its Director of Advocacy at that meeting. In the main, queries
had arisen from patients of a large private hospital in the region (who are treating one third of the
overall number of affected patients). Queries related mostly to information flow and rate of
throughput, given the numbers of patients involved.
In Nov 2011 the chairs of the Incident Management Team met with personnel from this private
Hospital in the South East to address operational and clinical issues that it was aware of. At that
meeting assurance was given to the HSE that there was no capacity or other issues that would
impact on the ongoing management of the treatment of their patients.
The HSE Director of Advocacy is liaising with the patient representative groups to ensure that any
queries that arise are resolved promptly on an individual basis, and ensure a channel of
communication between patient representative groups and sites/Incident Management Team is in
place to promptly address any queries or operational issues that may arise.
Matters ongoing –
At this point, of those patients whose clinical status was such as to require revision surgery, the
majority have already had surgery, or surgery is scheduled in the coming weeks/months. A smaller
number may require revision surgery based on current or developing clinical need.
As of June 2012, sites have commenced the second series of annual reviews for patients.
Any other matters e.g. request from Claims Handlers for additional product data for IMB, are being
addressed as they arise.
UK – MRHA Alert
In March 2012, an alert issued from the MRHA (UK) regarding the protocol for monitoring of
patients with metal on metal implants. A previous alert had issued in 2010
According to the MHRA, patients with a particular type of metal-on-metal hip replacement should be
monitored annually for the life of the hip replacement, rather than for the minimum 5 year postoperative period originally stated in April 2010.
This alert has been circulated by the Irish Medicines Board.
With regard to the implications of the revised guidance for the management of such patients, the
matter has been referred to the HSE Clinical Programmes Directorate who has sought input from the
Orthopedic Community, to inform further steps required.
Public Concern:
As with any recall of medical devices, there is a level of public concern regarding any longer term
effects/health implications, most noticeably regarding metal ion levels in bloods. While studies
have shown that metal ion levels may correlate with indications of a malfunctioning hip, protocols
on the use of this information in a clinical setting are still being defined
As information becomes available from clinical research, e.g. Orthopaedic Registries, and any other
developments, the information will be shared with Orthopaedic Surgeons to ensure that patient
safety remains paramount. However it is important to stress the that decision for a patient to have
revision surgery in based on assessment of clinical need, based on mutifactorial clinical assessment,
and it a decision that the patients is best placed to make in conjunction with their treating
Consultant.
De Puy Hip Implant Recall Incident Management Team & Terms of Reference
Name
Ms. Maria Lordan-Dunphy , Assistant National Director,
ISD, HSE and
Ms. Anne Carrigy, ISD,
representative and Co Chair (later replaced by Dr Siobhan
O’Halloran, Acute Hospital Services, HSE.)
Dr. Orla Healy, SIMT, Quality & Patient Safety Directorate
and Co Chair.
Mr. Stephen McMahon, Irish Patients Association.
Ms. Fidelma Brown, Communications Dept, HSE.
Mr. Patrick Kenny, Consultant, HSE Lead in Orthopaedics,
Institute of Trauma & Orthopaedic Surgery.
Clinical Expert
* replaced Nov. 10 by Mr B Curtin, Orthopaedic Surgeon,
I.I.T.O.S
Mr. Martin Quinlivan,
HSE Procurement
Ms Eunice O’Raw
H.S.E. Legal Services
Mr. Mark Fagan, Assistant National Director HSE
Finance
Mr Raymond Daly, I.C.T.
IT Projects Officer
Ms. Deirdre Coyne
Ms Colette Burns
Role
- Co-Chair of Incident Management Team.
- Co-ordinate, through the RDO’s, the management of DePuy Hip Implant Recall Incident
- Co-ordinate, through the RDO’s, the compilation of evidence of compliance with the pathway for
managing this incident from affected sites
- Provide updates on the status of the incident management to the Director of ISD at agreed intervals
- Co-Chair of Incident Management Team.
- Give technical support and guidance for the management of the incident
- Provide updates on the status of the incident management to the Head of the SIMT at agreed
intervals
- User Representative, quality assure information for patients and recall process
-
Communications/media management including support for communication to service users and staff
-
Develop clinical pathway for the identification and management of patients with problems arising
from the DePuy hip implant
Develop methods to determine compliance with this clinical pathway
-
Advise on the Procurement elements of this incident
-
Advise on the legal implications of this incident
-
Advise on the financial elements of this incident
-
Advise on the IT elements of this incident.
-
Project Support to Incident Management Team for QCCD Work
Project Support to Incident Management Team for ISD Work
Purpose of Incident Management Team.
To oversee the management of this incident including 1. Identification and management of cases arising from the DePuy ASR Hip Implant.
2. Appropriate follow-up, support and care of those affected by the DePuy ASR Hip Implant.
3. Optimum management communications to:

Service users and staff involved,

Through the Head of the SIMT to the CEO, HSE Management Team, and the Risk Committee, HSE.

External stakeholders through the Head of the SIMT (DoH&C; States Claims Agency; DePuy)

Public Communications
4. To liaise with DePuy to confirm that they will reimburse all costs (direct and indirect costs) arising from clinical assessment and management of
problems relating to the ASR Hip Implant.
5. To ensure that management of DePuy ASR Hip Implant Incident is conducted in a manner that impacts as little as possible on existing surgical waiting
lists.
6. Collaboration between the State Claims Agency (on behalf of the HSE) and DePuy to arrange the early provision of an indemnity by DePuy to the HSE to
cover future litigation against the HSE due to problems arising from the DePuy ASR Hip Implant
7. Provision of a report of the management of the incident to the Head of the SIMT.
8. Interim Report of De Puy Hip Implant Recall Incident Management Team will issue following the resolution of the declaration of the incident as a HSE
Serious Incident.
Incident Management Team will liaise with external stakeholders.
Timeline for Management of De Puy ASR Recall
26th Aug 10
De Puy Field Safety Notice – dated 24th Aug –circulated to Hospitals.
De Puy issues voluntary recall of ASR Hip Resurfacing System and ASR XL Acetabular System
HSE immediately notified all Orthopaedic Hospitals, Management and Consultants. HSE advises this product to be removed immediately.
27th Aug 10
4.30 p.m.
Meeting of representatives of HSE, IITOS, IMB, IHAI, DOHC, NTPF, PATIENT advocates. Addresses inter alia:
 Patient information/access/National & Hospital Helpline
 Validation of recall data.
 Identification of patients
 Communication with private and voluntary hospitals
 Irish Medicine Board liaison
 Liaison with external agencies e.g. DOHC/HIQA etc
 Identification of capacity for surgical review.
 Development of protocols for patient review/assessment.
5.30 p.m.
PEI representatives join meeting – tasked to provide clinical formation to IMB/IITOS, provide data to sites for validation, and agree clinical, financial,
other relevant issues to enable commencement of review of patients.
7.00 p.m.
Joint, HSE / IHAI press release issues.
HSE information line to operate at weekend as usual to address patient queries.
HSE requests list from De Puy of all components issued to each site
Teleconference with RDOs to brief on current status.
30th Aug 10
HSE Clinical Orthopaedic Lead & Director of Clinical programmes liaise with Irish Medicines Board regarding recall.
31st Aug 10
Meeting of HSE, Clinical Indemnity Scheme, IHAI, Patient Advocate, PEI, De Puy.
Addresses –
 HSE categorises recall as a ’Serious Incident’ under its Serious Incident Guidelines. SIMT members nominated to liaise with affected patients,
Statutory agencies, employees, public & Service user advocates, as required.
 Joint development of patient information pathways by De Puy/HSE Comms/Patient Advocate, parallel to patient pathways/review.
 Communication with De Puy
 Incident Management team to be convened to oversee all aspects of the national recall, including clinic arrangements, development of clinical




guidelines etc.
Process for reimbursement of review costs, and associated longer term costs.
Clinical Pathways/Patient review
Impact on current Orthopaedic waiting lists.
Blood testing
HSE receives transaction analysis list for all sites nationally from De Puy.
1ST Sept 10
HSE distributes transaction analysis lists to all sites, with instructions to reconcile components (with theatre lists etc) and to indentify affected
patients.
3rd Sept 10
Irish Institute of Trauma & Orthopaedic Surgeons issues recommendations to Orthopaedic Surgeons re ASR recall.
7th Sept 10
Incident Management Team inaugural meeting.
Terms of reference drafted
Current status of management of incident to date
Agreed steps for management of incident, including recall process/timing, clinical protocols, communication plan, costs, business continuity, IT
requirements/ information governance requirements etc.
2nd Sept 10
HSE C.E.O./Management Team updated of above and of arrangements to nationally oversee all aspects of the recall in a co ordinate fashion.
Each HSE Regional Director of Operations requested to nominate Senior link/contact person to Incident Management Team in each region to co
ordinate all aspects of recall.
8th Sept 10
First teleconference of Incident Management Team – agreed Terms of reference
9th Sept 10
Each RDO requested to provide written assurance to Incident Management Team that all components have been identified, removed from use, and all
patients have been identified.
Clinical Sub Group established – to provide expert advice to the management team and to liaise with relevant clinical colleagues. – comprising of
Consultant Orthopaedic Surgeon, Consultant Musculoskeletal Radiologist, Consultant Chemical Pathologist.
14th Sept 10
Incident Management Team meet
- work ongoing on drafting Clinical, and procedural guidelines.
HSE IMT issues set of detailed Procedures, Version 1 – covering –
Incident Management, preparing for Clinics,
Communication with patients – both those affected and other patients, Clinical Protocols and Recall Pathway, Information Governance and Reporting.
Whitfield Hospital (Private Hospital with cohort of 1100 patients) agree to join HSE IMT to ensure streamlined process for management of recall.
1st Oct 10
18th Oct
8th Oct 10
V2 of Incident management procedures issued, with updated reporting requirements.
10th Nov 10
12th Nov 10
V3 of Incident Management Procedures issued with update on Radiology Clinical Protocol.
IMT, HSE legal reps, De Puy Legal reps and personnel meet to resolve issue of patient consent and reimbursement process.
10th Dec 10
Majority of patients (2022) have received clinical appointment – those sites with large numbers of patients are triaging appointments based on
clinical need.
V 4 of Incident Management Procedures – update on management of legal correspondence.
Q & As updated to incorporate current developments
Agreement reached on requirements for reimbursement of revision surgeries without access to patient records.
Jan 11
Feb 11
May /11
June 11
Sept 11
V5 of Incident Management Procedures – Updated patient Q & A documents, Patient Consent option forms, explant decontamination instruction and
revise process for management of legal correspondence.
113 revisions undertaken
Agreement on tariff rates/tariff method of reimbursement of expenses incurred by sites in administering recall series.
October 11
Feb 12
July 12
V 5 Incident Management Procedures – Update patient Q & A documents, revised Patient authorisation forms ( incorporating further legal advice)
Meeting with De Puy Vice President, Medical Affairs, to outline HSE position regarding De Puy funding medical and monitoring costs on ongoing basis.
De Puy advise that they have committed to ongoing funding of costs incurred.
Decisions on patients ongoing care requirements is a matter for the treating Consultant - in consultation with the patient - based on clinical need.