Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).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 and was subsequently considered for revision due to unknown reasons.Surgeon requested a longer implant to be made.No additional information is available at this time.
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Event Description
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No additional information is available to report.
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Manufacturer Narrative
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The following report is being submitted to relay additional information received.Reported event was unable to be confirmed.Device history record review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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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