Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hip Fracture (2349)
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Event Date 01/15/2020 |
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.Device not returned for evaluation.
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Event Description
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It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient was revised due to periprosthetic fracture.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information. the following sections were radiographs were provided and reviewed by a health care professional.Review of the available records identified the following : comminuted and displaced periprosthetic fracture of the proximal right femur was observed.The femoral implant was subsided.No other abnormalities were noted.Reported event was confirmed by review of x-rays provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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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