Catalog Number 32810502706 |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 04/27/2011 |
Event Type
Injury
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It is reported the patient was revised due to a broken articulate pin.
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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.
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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 device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.This report is number 1 of 2 mdrs filed for the same patient (reference 0001822565-2016-04030).
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Further investigation confirmed that the humeral pin is packaged with the coonrad/morrey total elbow interchangeable humeral assembly, sharing the same product identification.The previous medwatch 3500a report submitted under this mfr number reported an unknown humeral pin incorrectly.The complaint sample was evaluated through device history record review and an x-ray review and the reported event was confirmed.X-ray report confirmed failure of locking pin and disassociation of locking pin.The report stated, "overall bone mineral density appears normal and there is no evidence of acute fracture.Marked pre-existing bony deformities distal humerus, proximal ulna and proximal radius including absence of distal humeral metaphysis/condyles and absence of proximal ulna and radius are factor known to increase risk of bushing wear and locking pin failure.As far as can be visualized, the humeral stem is grossly midline within the humeral canal.The tip of the ulnar stem is slightly off-center.Implant placement is unlikely a contributing factor to the reported event." the device history records were reviewed and no discrepancies were found.A review of the complaint history determined that no further action is required, as no trends were identified.A definite root cause was unable to be determined.
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Search Alerts/Recalls
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