Number One
White Rose Office Park
Millshaw Park Lane
Leeds LS11 0EA
Tel: +44 (0) 113 3877800
Fax: +44 (0) 113 3876087
August 24, 2010
URGENT FIELD SAFETY NOTICE
DePuy ASR™ Articular Surface Replacement and ASR™ XL Acetabular System
Type of Action: Removal of devices from the market (Recall)
FSCA Identifier: DINT 12725
Model number: All implant components of the ASR platform (see attached)
Batch / lot number of affected devices: All lots
Dear Clinicians:
As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the UK that demonstrated the ASR™ System had a higher than expected revision rate at 8-9 percent at three years when used with smaller head sizes (less than 50 mm diameter). The overall revision rate for ASR continued to be in line with the class of metal-on-metal monoblock systems based on the data available to DePuy at that time.
DePuy has just received new, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales. The data shows the five year revision rate for the ASR™ Hip Resurfacing System is approximately 12 percent and for the ASR™ XL Acetabular System is approximately 13 percent. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients.
Because the new NJR data shows a higher than expected revision rate at five years, DePuy is issuing a voluntary recall of all ASR products.
Reasons for revision identified within the datasets are consistent with those previously reported for ASR and include component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain.
Note: The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S. and the ASR™ XL Acetabular System was available worldwide.
Actions
Please share this notice (Document ID: DPYOUS2) with your organization and any organization
where the ASR products may have been transferred. Do not implant the ASR devices. Your
DePuy representative will assist with returns of any remaining inventory.
Patient Follow Up
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures. All other patients should be followed according to the April 22, 2010 and the May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.1, 2 Per the April 22, 2010 Device Alert, a small number of patients may develop progressive soft tissue reactions to metal wear debris. The debris can cause soft tissue damage which may compromise the results of the revision surgery. Early revision of poorly performing hip replacements that generate metal debris should give a better revision outcome. Therefore metal ion testing should be considered in cases where the surgeon is concerned about the hip replacement. The May 25, 2010 Alert specifies the following actions specific to the ASR:
• Follow up all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
• For patients who are symptomatic or implanted with a cup angle greater than 45°, particularly where a small component has been implanted:
o Consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scans
o If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
o If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
Financial Support for Patient Follow Up
DePuy Orthopaedics intends to cover reasonable and customary costs of monitoring and treatment for patients who might need such services associated with the recall of ASR.
Diagnostic testing, as recommended by the MHRA, may be used when surgeons have concerns about a patient with the ASR System. If, based on patient symptoms and/or the results of the diagnostic testing, the surgeon recommends a revision procedure, DePuy will provide this reimbursement.
Reimbursement is subject to the completion and submission of required documentation to DePuy to confirm eligibility. Eligibility will be determined, in part, by validation that the patient has an ASR component implanted and has consented to provide DePuy with x-rays, explants and any other requested medical information after the revision surgery.
Transmission of this Field Safety Notice
This notice needs to be passed on to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.
If you require additional information regarding this matter, please contact the DePuy Vigilance Manager on +44 (0)7771 971930. For clinical questions, please contact the following physicians:
Jens Krugmann, Director Product Safety and Risk Management, +353 87 6123 872
Dirk Parwis Ghadamgahi, Manager, Customer Education, +49172 446 6209
Greg Medalla, Manager Clinical Research, +44 113 387 7017
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has been made aware of this matter.
Sincerely,
Pamela L. Plouhar, Ph.D.
VP, Worldwide Clinical Affairs
References:
1. Medical Device Alert: All metal-on-metal (MoM) hip replacements. http://www.mhra.gov.uk/ Publications/ Safetywarnings/MedicalDeviceAlerts/CON079157
2. Medical Device Alert: DePuy ASRTM acetabular cups used in hip resurfacing arthroplasty and total hip replacement. http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON082089
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