Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Ossification (1428); Bone Fracture(s) (1870); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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's left hip was revised due to unknown reason.The stem was revised.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Review of the available records identified that there was a comminuted fracture of the proximal left femoral diaphysis and extensive heterotopic ossification along the wall neck suggesting limited mobility.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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