(b)(4), visual examination of the returned product identified signs of being implanted wear/discoloration and the post has fractured off.The post fracture on the item was the result of overloading, possibly exacerbated by impingement from the femoral component, and possibly also exacerbated by misalignment of the femoral with the tibial component.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the complaint is for the cam breaking off of the ps bearing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|