It was reported that after an unspecified primary thr surgery performed around 1997, the patient started experimenting pain around (b)(6) 2018, an x-ray confirmed erosion of the femoral component.In (b)(6) 2019, the patient underwent a revision surgery secondary to polyethylene wear debris, which caused osteolysis of the femur and femoral loosening.The stem, femoral head and liner were replaced.7 months later the patient underwent a second revision surgery due to a fracture of the newly implanted stem (covered under (b)(4)).
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, with the information provided the clinical root cause of the reported polyethylene wear debris, and subsequent osteolysis of the femur and femoral loosening cannot be definitively confirmed.However, aged, related wear was the likely cause the reported failure.We cannot rule out the patient¿s body habitus (morbid obesity bmi 42.48) and the cement breakage as contributing factors to the reported failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness, lifetime of device, patient condition or cement breakage.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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