(b)(4).Initial report: customer has indicated that the product has been discarded, therefore will not be returned to zimmer biomet for investigation.Concomitant medical products: medical product: oxf twin-peg cmntd fem lg pma, catalog #:161470, lot #: 915290.Medical product: oxf uni tib tray sz d rm pma, catalog #:154725, lot #: 734830.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00373, 3002806535-2021-00374.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4) this final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.The source of pain cannot be determined through the radiographs, as only ap radiographs provided, no ml view so a full assessment of size, position and alignment cannot be done.A review of the manufacturing history records confirms no abnormalities or deviations reported, (b)(4) and (b)(4) were issued for item 161470 and ncr0024 was issued for item 154725.A review of the complaint database over the last 3 years has found 4 complaints reported with the item 159583, 5 complaints reported with the item 161470 and 6 complaints reported with the item 154725 (including the initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: (b)(4) if any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
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