Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
|
Patient Problems
Fall (1848); Failure of Implant (1924); Joint Dislocation (2374)
|
Event Date 02/09/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # 11-301312/ arcos con sz b hi / lot # 267450; part #unknown / unknown head/ lot # unknown; part #unknown / unknown liner/ lot # unknown; part #unknown / unknown screw/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00604.
|
|
Event Description
|
It was reported that patient was revised one-year post implantation due to a fall causing dislocation.During the revision it was discovered the taper junction between the arocs cone body and stem was not engaged.However, the set screw was found to be in place.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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.
|
|
Search Alerts/Recalls
|