(b)(4).Brand name: tibial component pegged precoat for cemented use only size 3.Concomitant medical products: nexgen pre-coat cr-flx gender femoral component, catalog #: 00575001401, lot #: 61886308.Prolong cr-flex nexgen articular surface, catalog #: 00595203010, lot #: 62638441.All poly patella standard size 29 mm diameter 8.0 mm thickness for cemented use only, catalog #: 00597206629, lot #: 62257591.Device evaluated by mfr: customer has indicated product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation is completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00139, 0001822565-2019-01764, 0001822565 -2019-01880.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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Reported event was confirmed by review of medical records.Medical records note that the patient was treated for swelling 3 weeks post implantation.Device history record (dhr) was reviewed and no discrepancies were found.Per package insert: swelling is a known adverse effect of this system.However, a definitive root cause cannot be determined.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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