Model Number N/A |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
No Information (3190)
|
Event Date 01/10/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant product: p/n 139252 m2a-magnum 42-50mm tpr insrt-6 l/n 470670.P/n 103206 taperloc por fmrl 12.5x145 l/n 500550.P/n us157856 m2a-magnum pf cup 56odx50id l/n 488400.The devices were not returned for evaluation to the manufacturer at this time.No further information has been made available.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that during a hip revision procedure, the femoral head was found cold welded onto the trunnion.After multiple attempts to disimpact the head, a metal cutting burr was used to remove the head.The well-fixed femoral stem remained implanted.This resulted in a one hour delay in procedure.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision operative report.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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.
|
|
Search Alerts/Recalls
|