Device Recall DEPUY ASR RESURFACING FEMORAL HEADS 의 리콜

Recall

57177

Class 2

Z-1775-2011

2010-08-23

2011-03-24

Terminated

United States

2013-08-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96085

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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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.

DePuy 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.