(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00592.0001825034 - 2024 - 00593.0001825034 - 2024 - 00594.0001825034 - 2024 - 00777.D10: cat# 650-1065 lot# 835650 cer option type 1 tpr sleve -3.Cat# 650-1057 lot# 620880 cer bioloxd option hd 36mm.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 a patient had an initial left total hip arthroplasty.Approximately 14 years later the patient had a chronic trochanteric avulsion fracture and developed pain, stiffness, range of motion issues, and a fall that led to ongoing diagnostic tests with suspicion of alval.The patient underwent a revision due to infection.During the procedure, a small fracture of the anterior cortex occurred from the wedging of the osteotome.All implants were removed, and a competitor cement spacer was implanted.Attempts have been made and no further information has been provided.
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