Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/03/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent shoulder arthroplasty on an unknown date for an unknown reason.Subsequently, the patient was revised due to unknown reasons approximately three (3) weeks ago.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03193.Concomitant medical products: item#: unknown, unknown versa dial head; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was discarded by hospital.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).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03193-1.After receiving additional information and reassessment, the item was determined to be not reportable.The tendon tear is unrelated to the implant.The patient was revised due to rotator cuff deficiency.
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Event Description
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It was reported that the revision was caused by the patient's rotator cuff being deficient and not caused by a malfunction of the implant.
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Search Alerts/Recalls
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