Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Cyst(s) (1800)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: custom lt ibp med humeral comp, catalog #: cp560539, lot #: 750420.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent an initial elbow arthroplasty on (b)(6) 2002.Subsequently underwent a procedure in 2011 for triceps" blackened cyst".No additional information is available from the event.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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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It was reported that the patient underwent an initial elbow arthroplasty.Subsequently underwent a procedure for triceps" blackened cyst".No additional information is available from the event.
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Search Alerts/Recalls
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