(b)(4).Medical devices: oxford uni twin-peg femoral xs item# 166940 lot# 6839631, oxf uni tib tray sz d rm pma item# 154725 lot# 6937758.Foreign: (b)(6).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: 3002806535-2022-00319, 3002806535-2022-00320, 3002806535-2022-00321.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment are maintained, there is no sign of loosening.No dislocation is identified on the images.However, a dislocation could certainly cause symptoms such as pain and swelling and the need for a revision.The root cause of the reported issue is attributed to patient non compliance based upon the information provided by the surgeon and supported by the operating surgeon's assessment.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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