Model Number N/A |
Device Problems
Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Perforation (2001)
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Event Type
Injury
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Manufacturer Narrative
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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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action(s) is/are required.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 during right elbow arthroplasty, the long ulnar component didn¿t fit into the medullary cavity and punctured the patient¿s ulna.The surgeon attempted to bend the ulnar component, but alternatively decided to use a shorter ulnar component to complete the procedure.No additional patient consequences were reported.Attempts have been made to retrieve additional information, but no further information is available at this time.
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Manufacturer Narrative
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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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action(s) is/are required.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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Search Alerts/Recalls
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