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Model Number N/A |
Device Problems
Unstable (1667); Noise, Audible (3273)
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Patient Problems
Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Numbness (2415)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: us-115740 humeral component, lot 115220; 118001 taper adaptor, lot 381590; 113053 humeral head, lot 101640; 113956 glenoid base, lot 468830; pt-113950 regenerex peg, lot 304740.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08878, 0001825034-2018-08879, 0001825034-2018-08881.
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Event Description
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It was reported patient underwent a right total shoulder arthroplasty.Subsequently, the patient experienced a popping sensation/noise in the operative shoulder, beginning approximately three (3) months post-operatively.Numbness, tenderness, and muscle fatigue/spasms in the operative arm were further reported at two (2) year follow-up.Pain with crepitus, instability, and impingement have been reported as ongoing.The patient has not been revised and is monitored within the study.No further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed with patient medical records.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 information is available.
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Search Alerts/Recalls
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