*us legal* it was reported that, after a left thr on (b)(6) 2016 due to end-stage degenerative joint disease of both hips with vascular necrosis.Revision surgery was performed on (b)(6) 2019 due to a complicated postoperative course, chromium and cobalt levels on the implants reflected increasing cobalt levels in the 15-16 range combined with fluid and increasing/persistent pain.Patient outcome is unknown.
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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, the reported pain, mechanical loosening, cobalt level 15-16 (no unit of measure), fluid and intraoperative findings of corrosion with black interfaces on the femoral neck and stem may be consistent with metal debris.However, the clinical root cause of the reported clinical reactions/events cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined; however, it is noted the patient had a 2nd revision 4 months later due to infection.A review of complaint history did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the instructions for use documents and risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.An historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The contribution of the device to the reported event could not be corroborated.Possible causes could include but are not limited to patient's medical history/condition, lack of ingrowth, material in use or patient reaction.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.
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