(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02539, 0001822565-2022-02541.Concomitant medical products: item#: unknown, unknown glenoid, lot#: unknown.Item#: unknown, unknown humeral stem; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.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 follow-up report is being submitted to relay additional/corrected information.Upon receiving additional information of the reported event, it was determined to be not reportable as the infection was greater than 90 days post-operatively.The initial report should be voided.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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