Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Connective Tissue Disease (1786)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a right shoulder arthroplasty for an unknown reason.Subsequently, the patient has been indicated for a revision due to rotator cuff deficiency and glenohumeral arthritis.
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).Upon receipt of additional information, it was determined this product should not have been reported under this mfr number 0001825034-2022-00081-1.This report should be voided and a corrected report will be filed under mfr number 0001822565-2022-00342.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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