(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00974.0001825034 - 2023 - 00975.0001825034 - 2023 - 00976.D10: cat#103531 lot# 008980 ti low profile screw 6.5x20mm cat# 103534 lot# 452840 ti low profile screw 6.5x35mm the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that the patient had a left total hip arthroplasty that was subsequently revised approximately 11 years later.It was noted an increase in clicking and development of pain.Radiographic imaging showed the femoral head popped off the trunnion even though the femoral head remained in the acetabulum and articulating with the cup.During the revision, the femoral component was found severely damaged, deformed, and corroded.Osteolysis found in the region of the calcar, an extended osteotomy was performed for removal of the well-fixed femoral component, the acetabular liner was broken from the trunnion hitting into it, and the locking ring was deformed.Luque wires were implanted to support the extended osteotomy.The cup remained without damage and was left in place.The locking ring and liner were revised, and all other implants were replaced with competitor product.Attempts have been made and no further information has been provided.
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