Reported event: an event regarding wear and loosening involving a scorpio baseplate was reported.Wear was confirmed via evaluation of the provided photographs of the device.Loosening was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicated that the device has a small area of wear on the inner side of the posterior edge.The device exhibits residue and minor scratches consistent with explantation.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a cemented scorpio total knee arthroplasty in 2017.According to the summary the implant was removed on (b)(6), 2022 for "aseptic loosening of the prosthesis." i cannot confirm that revision occurred since i have no supporting evidence to document this such as office notes, an operation note or post revision x-rays.I also cannot confirm that aseptic loosening of the prosthesis occurred.The x-rays provided, in my opinion show that the patient has gross instability of the implant.I see no evidence of loosening of either the femoral or tibial component but, granted, only two x-rays are provided.The causes of late instability of a cemented total knee arthroplasty are multifactorial including surgical technique, patient factors including bmi and activity level.It would be unusual to implicate implant factors as a cause of instability." -product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to aseptic loosening.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicated that the device has a small area of wear on the inner side of the posterior edge.The device exhibits residue and minor scratches consistent with explantation.A review of the provided medical information by a clinical consultant indicated: "this patient underwent a cemented scorpio total knee arthroplasty in 2017.According to the summary the implant was removed on (b)(6), 2022 for "aseptic loosening of the prosthesis." i cannot confirm that revision occurred since i have no supporting evidence to document this such as office notes, an operation note or post revision x-rays.I also cannot confirm that aseptic loosening of the prosthesis occurred.The x-rays provided, in my opinion show that the patient has gross instability of the implant.I see no evidence of loosening of either the femoral or tibial component but, granted, only two x-rays are provided.The causes of late instability of a cemented total knee arthroplasty are multifactorial including surgical technique, patient factors including bmi and activity level.It would be unusual to implicate implant factors as a cause of instability." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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