(b)(4).Concomitant medical products: tprlc 133 t1 pps ho 12x144mm: cat# 51-104120, lot# 3727047 tprlc133 mp t1 pps so 6x97.5mm: cat# 51-108060, lot# 2569203 tprlc xr t1 pps 14x148mm: cat# 51-105140, lot# 2931353 tprlc xr t1 pps 17x154mm: cat# 51-105170, lot# 2844723 tprlc 133 t1 pps ho 13x146mm: cat# 51-104130, lot# 3714345 tprlc 133 t1 pps so 15x150mm: cat# 51-103150, lot# 3386951 tprlc xr t1 pps 16x152mm: cat# 51-105160, lot# 2990162 tloc 133 mp sp t1 ppsho 6x97.5: cat# 51-109060, lot# 3433002 tprlc 133 t1 pps ho 16x152mm: cat# 51-104160, lot# 3219007 tprlc 133 t1 pps so 10x140mm: cat# 51-103100, lot# 3446079 tprlc 133 t1 pps ho 17x154mm: cat# 51-104170, lot# 2525467 tprlc 133 fp type1 pps ho 7.0: cat# 51-101070, lot# 3354575 tprlc xr t1 pps 15x150mm: cat# 51-105150, lot# 2867459 tprlc 133 fp type1 pps ho 6.0: cat# 51-101060, lot# 2552323 tprlc 133 t1 pps ho 15x150mm: cat# 51-104150, lot# 2563641 report source: foreign country: (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: 0001825034-2020-00534.0001825034 -2020-00535.0001825034-2020-00536.0001825034-2020-00537.0001825034-2020-00538.0001825034-2020-00540.0001825034-2020-00541.0001825034-2020-00542.0001825034-2020-00543.0001825034-2020-00544.0001825034-2020-00545.0001825034-2020-00546.0001825034-2020-00547.0001825034-2020-00548.0001825034-2020-00549.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d10, g4, h2, h3, h6 complaint sample was evaluated and the reported event was confirmed.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned products identified that there was debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier and black debris consistent with porous material from the device.Device history record (dhr) was reviewed and no discrepancies were found.Device history record (dhr) was reviewed and no discrepancies were found.These products were likely conforming when they left zimmer biomet control.The root cause of the reported issue is attributed to transit damage causing the foam packaging and porous material from device to become abraded and shed.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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