(b)(4).Report source: (b)(6).Product is in process of being returned to zimmer biomet for the investigation and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02742, 0001825034-2020-02744, 0001825034-2020-02745, 0001825034-2020-02746, 0001825034 - 2020 - 02747.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d10; g4; h2; h3; h4; h6.Complaint sample was returned and evaluated against the reported event.Evaluation of the returned product/photographs provided confirmed the following: debris inside the sterile packaging which is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier.Dhr was reviewed and no discrepancies were found.The root cause of the reported event is likely to be due to transit damage.The likely condition of the product when it left zimmer biomet was conforming to specification.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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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