Model Number N/A |
Device Problems
Failure To Adhere Or Bond (1031); Insufficient Information (3190)
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Patient Problems
Inadequate Osseointegration (2646); No Information (3190)
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Event Date 02/23/2016 |
Event Type
Injury
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It is reported that the patient is experiencing unknown injury due to the implant.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial report.Concomitant products:
item # 42500807001, persona tm standard femoral, lot # 62688449;
item # 42512401010, persona ps ve articular surface, lot # 62706147;
item # 42540200035, persona ve all poly patella, lot # 62826593.
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Event Description
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It has now been reported that the patient was revised due to tibial loosening.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Corrected: common device name and product code.Reported event was confirmed through review of medical records.Review of device history record found no discrepancies relevant to the reported event.Root cause of the event is attributed to the design of the device, which has been the subject of a previous corrective action.It was determined that this device was manufactured prior to the corrective action.No further action is required at this time.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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Additional information received in revision operative report indicates failed right uncemented total knee arthroplasty secondary to failed bony ingrowth of the tibial component.
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Search Alerts/Recalls
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