Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that a patient is being considered for a revision procedure on an unknown date due to potential rotator cuff failure.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of the humerus firmly within the shallow socket of the shoulder.Rotator cuff injuries occur most often in people who repeatedly perform overhead motions or experience any sort of trauma to the shoulder.Degenerative tears can also occur because of gradual wearing down of the tendon.This degeneration naturally occurs as we age.Factors that lead to degenerative tears include repetitive stress, lack of blood supply, bone spurs, and increased age.Common symptoms of a rotator cuff tear include pain at rest or with activity, weakness, and crepitus.Typically, an anatomic shoulder is performed when the rotator cuff is stable and intact, and a reverse shoulder is performed for an insufficient rotator cuff.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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Event Description
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under (b)(4) zimmer.
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Manufacturer Narrative
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Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under (b)(4) zimmer.
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Search Alerts/Recalls
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