It was reported that implant date occurred between (b)(6) 2020 and (b)(6) 2020.Concomitant medical products: medical product: unknown persona femoral component catalog#: ni, lot#: ni, unknown persona tibial trays catalog#: ni, lot#: ni, stryker bone cement catalog#: ni, lot#: ni.(b)(4).Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02442, 0001822565-2021-02444.
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It was reported that patient underwent a total knee arthroplasty at an unknown date.Between 8 and 20 months post implantation, patient began experiencing pain, swelling and localized rash.Products remain implanted.Attempts have been made and no further information was provided.
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