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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, 0001825034-2018-08880, 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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It was determined this device did not cause or contribute to the reported event.Please void this submission.
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Event Description
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No further information.
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Search Alerts/Recalls
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