An event regarding loosening & pain involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product remains implanted.- clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: x-ray printouts include a series dated november 1, 2019, which is an ap of the pelvis and lateral of the right hip demonstrating bilateral uncemented total hip arthroplasties with no screws in the acetabular component.The right hip demonstrates brooker iii heterotopic ossification.X-rays dated (b)(6) 2019 are an ap of the pelvis and lateral of the right hip, which is unchanged.Based upon the information available for review, there is no indication that any symptoms described as related to the right total hip arthroplasty are due to the prosthetic components and the recall of the implanted prosthetic femoral head.Persistent lumbar pathology and radicular pain, as well as heterotopic ossification are more likely the cause of the symptoms described.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the patient would like to know if his implants were part of a recall.The trident shell was determined not to be involved in recall.The exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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