Model Number N/A |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/10/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during a total knee arthroplasty, the tibial insert would not seat on the tibial tray.The procedure was completed using another tibial insert that was on hand.No adverse events have been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
(b)(4).G2 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.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows the locking features to be flared out and the distal surface exhibits damage in various areas.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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
|