(b)(4).D10 - oxford pks cemented tibia, alpha, standard - lm size b, item# (b)(4), lot# 777150; oxford pks twin peg femur - small, item# (b)(4), lot# 913310.Multiple mdr reports were filed for this event, associated reports: 3002806535-2023-00231; 3002806535-2023-00233.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 and/or corrected 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.A medial unicompartmental arthroplasty is present.There is abnormal position of the tibial implant with oblique orientation on the lateral view and probable posterior implant subsidence.Alignment is overall maintained.Correlation with earlier images would be of value.Bone quality is osteopenic.No other abnormalities are identified.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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