Smith and Nephew Hip Recall Attorneys
Smith & Nephew PLC announced a recall of 185 hip replacement implants in August 2007, after patients were forced to have surgery to replace improperly fitted devices. The recall was due to mislabeled products, causing a mismatch between implant pieces. These mismatched pieces can cause the implant to fit loosely.
Smith & Nephew does not know how many of the 185 devices have been implanted, and patients who have already received the implants are being x-rayed to see if the devices are fitted correctly. Doctors are asked to review post-operation x-rays to see if their patients implants have been improperly fitted, and if another operation should be considered.
FDA Warning to Smith and Nephew
The FDA issued a warning to Smith & Nephew PLC in December 2010 about quality control problems at their German hip replacement implant facility, stating its processes to validate and verify the quality of its products lack in several areas. The plant is responsible for the manufacturing of the R3 Ceramic Acetabular System. Inspectors found a failure to confirm the validity of the plant’s minimum and maximum settings for a titanium ring press, and stated the plant failed to verify that corrective actions taken to fix a problem where radiation-sterilized parts were not getting enough radiation were working. The problem recurred later, and the plant blamed it on employees not following the new procedures.
If you have received a Smith and Nephew hip implant, we would like to review your case. Also, any individuals who are unsure of the type of hip device implant they may have received, or anyone who has had a revision surgery.
Contact Goldenberg Heller & Antognoli, P.C.
If you or a loved one have had problems with a Smith and Nephew Hip, please contact us today at 618-656-5150 or toll free at 800-782-8492 to schedule a free initial consultation with one of our experienced hip replacement attorneys. We handle all medical device litigation on a contingency fee basis. You pay nothing for our services unless we obtain a settlement or an award on your behalf.