Model Number N/A |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/14/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source: foreign source: japan customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that during a knee procedure, the tibial insert would not seat on the tibial tray.The procedure was completed with another tibial insert that was on hand.No adverse events have been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product found the locking features to be flared and damaged.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|