(b)(4).D10: oxf uni tib tray sz d lm pma; item#154724; lot#838200.Oxf anat brg lt md size 3 pma; item#159547; lot#744230.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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00139, 3002806535 - 2023 - 00140.
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10.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.Devices are used for treatment.Medical records/radiographs were provided and reviewed by a health care professionel/radiologist.Significant findings include periprosthetic lucency surrounding the medial tibial component of the unicompartmental arthroplasty likely represents loosening potentially infection.There appears to be joint space loss in the medial compartment with possible metal on metal contact, which is a nonspecific finding and could be related to subsidence of the tibial component hardware.Alternatively, polyethylene wear can result in similar findings.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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