The alleged complaint is not confirmed.Microport was made aware of this revision through (b)(6) registry data.It was indicated that both resurfacing components were revised due to periprosthetic femoral fracture, which would comprise of the femoral resurfacing head in this case.The revised products have not been returned for investigation.Additionally, no images or operative notes were provided to confirm the complaint.Review of the device history record (dhr) for these lots indicates that these products met all established acceptance criteria throughout the manufacturing process.Review of historical complaint data reveals no lot trends for this issue.This is the first complaint for this lot and issue.These products had been implanted for approximately 142 months until revision.No conclusions regarding the femoral fracture can be made from the available information.The microport hip systems package insert (150803-8) lists "femoral or acetabular perforation or fracture; femoral fracture while seating the device; femoral fracture by trauma or excessive loading, particularly in the presence of poor bone stock" as potential adverse effects of total hip arthroplasty (tha).There is not a trend for this device and incident mode per mpo trending procedures.This issue will continue to be monitored through complaint tracking.
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