(b)(4).D10 - medical devices: oxf uni tib tray sz c rm pma; item# 154723; lot# 007610.Oxf anat brg rt md size 3 pma; item# 159575; lot# 942780.Multiple mdr reports were filed for this event: 3002806535-2023-00121; 3002806535-2023-00122.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.Significant findings include that the unicompartmental knee arthroplasty, involving the medial compartment of the right knee, appears anatomically aligned without periprosthetic lucencies.A threaded screw is noted extending from the level between the tibial spines inferolaterally to closely approximate the lateral cortex of the tibial metaphysis.The proximal tip of the screw appears slightly backed out with positioning at the level of the anterior intercondylar notch.Linear radiodensity in the medial compartment joint space is likely related to the normal appearance of the polyethylene lining.Bones appear intact and normally mineralized.The left knee imaging demonstrates moderate to severe degenerative arthritic changes with joint space loss in the medial compartment.Possible backing out of the screw in the proximal tibia with the proximal head located in the anterior intercondylar notch.It is uncertain if this is related to subsidence/loosening from a previous time point.A definitive diagnosis can be made by comparing with previous imaging.Otherwise, the unicompartmental knee arthroplasty appears intact without periprosthetic lucencies.No fractures were detected.The overall fit alignment of the implants, as well as bone quality, appears normal.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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