(b)(4).Concomitant medical products: catalog #: 47494500411, 4.5 mm l-buttress plate angled left 4 holes, lot #: unknown.Catalog #: unknown, unknown screws, lot #: unknown, qty.(b)(4).Report source: france.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.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: 0001822565-2022-02741, 0001822565-2022-02745, 0001822565-2022-02746, 0001822565-2022-02747, 0001822565-2022-02748, 0001822565-2022-02749, 0001822565-2022-02750, 0001822565-2022-02751, 0001822565-2022-02752.
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This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Upon receipt of additional information, it has been determined that the device did not cause or contribute to the reported event.The device did not loosen, but osteonecrosis contributed to migration with a few bone parts.The initial report was forwarded in error and should be voided.
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