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Catalog Number SAGP0002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Muscle/Tendon Damage (4532)
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Event Date 07/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02336, 0001822565-2023-02341, 0001825034-2023-02038.D10: 3 peg mod glen sz 2 cat: sagl2032 lot: 64748989.Versa-dial 46x18x53 hum head cat: 113042 lot: 7157360.Comp primary stem 13mm micro cat: 113613 lot: 65319596.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product remains implanted.
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Event Description
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It was reported that patient began to have severe shoulder pain, moderate difficulties completing daily activities, limited range of motion, and muscle weakness approximately ten months post operation.The patient reports sharp popping pain in the anterior shoulder with a twisting motion.No additional patient consequences were reported.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 additional information to report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, g3, h2, h6 the reported event was confirmed by review of the provided clinical report.The root cause of the event is traced to non-device related factors; a review of the device history records was not performed.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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