|
Model Number IBAL UKA TIB CEMENTED TRAY, SIZE 5 RM/LL |
Device Problem
Fitting Problem (2183)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 03/13/2024 |
Event Type
malfunction
|
Event Description
|
On 03/13/2024, it was reported by a sales representative via e-mail that ((2) ar-521-tbe8 ibalance® uka tibial bearing implants were not locking into the ar-511-t5r ibalance® uka tibial tray.This occurred during a case.No additional information was provided, and additional information has been asked.
|
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Search Alerts/Recalls
|
|
|