Smith & Nephew has released an Urgent Field Safety Notice regarding their BIRMINGHAM HIP Modular Heads with thousands of defective devices being recalled. This device recall affects the Modular SMF and Modular REDAPT femoral replacement hip systems totaling close to 20,000 devices.
Smith & Nephew’s Urgent Field Safety Notice lists “Inflammatory tissue response to high levels of wear debris resulting in peri-prosthetic aseptic lymphocyte dominated vasculitis associated lesions (ALVAL), fluid collections, or soft tissue masses (Pseudo-tumors)” as possible adverse effects.
In a related FDA Class 2 Device recall the FDA determined the cause of the recall to be “device design”. With Smith & Nephew listing “a higher than anticipated complaint and adverse event trend.” as the reason for recall.
Birmingham Hip Resurfacing (BHR) System Reported Adverse Effects
- Revision surgery
Birmingham Hip Replacement Lawyers
Our experienced Smith & Nephew Birmingham hip replacement lawyers are ready to help. If you or a loved one are experiencing complications with a Smith & Nephew hip replacement system, call 1800LAW1010 (1-(800) 529-1010) for a free, no obligation consultation. We have several offices throughout New York State and Vermont to better serve you, and our team is available day and night to help.
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