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U.S. Department of Health and Human Services

Class 2 Device Recall DEPUY ASR ACETABULAR CUP SYSTEM

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 Class 2 Device Recall DEPUY ASR ACETABULAR CUP SYSTEMsee related information
Date Initiated by FirmAugust 23, 2010
Date PostedMarch 24, 2011
Recall Status1 Terminated 3 on August 29, 2013
Recall NumberZ-1794-2011
Recall Event ID 57177
510(K)NumberK040627 
Product Classification Prothesis, hip, semi-constrained (metal uncemented acetabular component - Product Code KWA
ProductASR TAP SLV ADAP 12/14 +8, DEPUY ASR ACETABULAR CUP SYSTEM, ASR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL). The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. Prescription Use, Sterile. The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Code Information Part Number 999800318, ASR Taper Sleeve Adapter Size 12/14 +8, All lots.
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactASR Helpline
888-627-2677
Manufacturer Reason
for Recall		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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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
FDA Determined
Cause 2		Device Design
ActionDePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices. 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 May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts. Follow up for 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 degrees, particulary where a small component has been implanted.: " Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans. " 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 " If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered. DePuy representatives were to assist with returns of any remaining inventory. For questions regarding this recall call 574-372-7333.
Quantity in Commerce4,158
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWA
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