(b)(4).Concomitant medical products: tprlc xr mp t1 pps 15x115mm 115mm t1, cat#51-145150, lot#3577455.Tprlc 133 mp type1 pps so 17.0 1, cat#51-106170, lot#3305289.Tprlc xr mp t1 pps 15x115mm 115mm t1, cat#51-145150, lot#2931560.Tprlc 133 mp type1 pps ho 15.0 m t1, cat#51-107150, lot#3577540.Tprlc 133 t1 pps ho 15x150mm 0mm t1, cat#51-104150, lot#2429229.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001825034-2020-00755, 0001825034-2020-00758, 0001825034-2020-00759, 0001825034-2020-00760, 0001825034-2020-00761.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h2, h3, h6, h10 correction: h4 evaluation of the returned product/photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.The reported event is confirmed and sterility of the product is intact.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed.The event is being addressed through the capa process.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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