(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted concomitant medical products: item # 51-145170/ tprlc xr mp t1 pps/ lot # 6411825, item# 51-105170/ tprlc xr t1 pps/ lot # 3011823, item # 51-105160/ tprlc xr t1 pps /lot # 6133648, item# 51-107140/ tprlc 133 mp type1 pps/ lot# 6359748, item# 51-107170/ tprlc 133 mp type1 pps/ lot# 3743544, item# 51-145140/ tprlc xr mp t1 pps / lot# 6314883.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports 0001825034-2021-00357, 0001825034-2021-00358, 0001825034-2021-00359, 0001825034-2021-00360, 0001825034-2021-00361, 0001825034-2021-00362.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected
updated: d4; d9; g3; h2; h3; h4; h6
visual evaluation of the returned product/photographs provided confirmed there is white 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.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is likely to be due to transit damage causing the foam packaging and porous coating to become abraded and shed.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Further, there was no adverse event as a result of the reported event.Therefore, event is no longer considered reportable, and initial report should be voided.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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