Declaration of the Smith and Nephew Hip Replacement Recall

Smith & Nephew PLC declared a recall of 185 hip replacement implants in August 2007, after affected individuals were required to have surgery to replace incorrectly attached devices. The recall was because of mislabeled devices, leading to a mismatch between implant parts. These mismatched pieces can cause the implant to fit loosely.

Smith & Nephew are unable to know how many of the 185 systems are implanted and affected individuals who have already obtained the implants have been x-rayed to check if the devices are attached properly. Medical professionals are requested to evaluate post-operation x-rays to check if their patients’ implants are improperly attached, and if a second surgery should be considered.

The FDA sent a notice to Smith & Nephew PLC in December 2010 regarding quality control issues at their German hip replacement implant service, declaring its procedures to verify and validate the standard of its devices lack in some areas. The manufacturer is liable for the production of the R3 Ceramic Acetabular System. Inspectors discovered an inability to verify the quality manufacturer’s minimum and maximum adjustments for a titanium ring press, and said the manufacturer was unsuccessful to validate that corrective measures taken to solve an issue where radiation-sterilized parts were not having enough radiation were working. The issue recurred later, and the manufacturer charged it on staffs not following the new methods.

For those who have obtained a Smith and Nephew hip implant, we would like to evaluate your [REMOVED BY ADMIN]. Also, any people that are uncertain of the kind of hip system implant they may have obtained, or anyone who has had a modification procedure.