Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 04/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, as the device has been discarded; however, an investigation of the reported event is in progress.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 a revision procedure of the left hip approximately three (3) days post implantation due to periprosthetic fracture after a fall two (2) days post implantation.The fracture was secured with a plate and cables, and the femoral head and stem were replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - stem.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: diagnosed with periprosthetic fracture after a fall.Femoral component removed, no other complications noted.Device history record was reviewed and no discrepancies relevant to the reported event 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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Search Alerts/Recalls
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