Catalog Number 00840009400 |
Device Problem
Component Incompatible (1108)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant medical products: catalog #00840004410, zimmer nexel plasma sprayed humeral component, lot #63313335; catalog #00840001407, zimmer nexel plasma sprayed ulnar component, lot #63169548.
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Event Description
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It was reported that the axle pin and ulnar bearings were not able to be assembled with the ulnar component during elbow arthroplasty.No further information is available.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.No devices or photos were returned for evaluation.The device history records were reviewed for the pin and bearings with no deviations or anomalies being identified.This device is used for treatment.The complaint history review was conducted for the devices and found no additional complaints for the same lots.Surgical technique and notes were not provided.A definitive root cause of the reported issue cannot be determined with the information provided.
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Manufacturer Narrative
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This follow up report is being submitted to relay additional information.Dhr was reviewed and no discrepancies relevant to the reported event were found.The complaint sample was evaluated and the reported event could not be confirmed as no issues were identified.The articulation kit was received and the axle pin and ulnar bearings were able to assemble with the ulna component, contradictory to the reported event.A root cause was unable to be determined as device analysis indicated that the device met specification and the complaint could not be substantiated.
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Search Alerts/Recalls
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