Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.
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Due to hip osteoarthritis was done right hip at (b)(6) 2010 and left hip at (b)(6) 2011 with "centpiller" tmzf stem, trident cup, v40 head and x3 liner.At (b)(6) 2017, the patient noticed a tumor of both hip joint at the setting position and visit a hospital.Tumor of both hip joint was confirmed at mri.Serum co ion concentration was as high as 23.5ng/ml, and the doctor suspected a pseudotumor by armd.At (b)(6) 2017, left revision surgery was done because of a pressing pain in the left hip joint tumor of the patient.A head and liner was replaced new devices, because the fixation of the cup and stem was good.According to intraoperative findings, a white pseudo tumor was generated from inside the joint cavity, and adherence of black abrasion powder was observed in head-neck junction.Four months after operation, tumor reformation was not confirmed.
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