Model Number 00-4349-039-12 |
Device Problems
Unstable (1667); Detachment of Device or Device Component (2907)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 02/07/2023 |
Event Type
Injury
|
Event Description
|
It was reported that the patient's shoulder was unstable.Subsequently, the patient was revised due to disassociation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
|
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00599.Concomitant medical product(s): 40mm ã¿ +6mm offset poly liner cat: 00434904006 lot: 64163191; 40mm ã¿ glenosphere cat: 00434904011 lot: 64844921.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 report will be submitted.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|