ZIMMER BIOMET, INC. CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM THICKNESS; PROVISIONAL, KNEE
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Disassembly (1168)
|
Patient Problem
No Information (3190)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Returned, not yet evaluated.
|
|
Event Description
|
It is reported that the provisional was returned without one of the ball bearings and springs.Attempts were made, but no additional information can be provided.
|
|
Manufacturer Narrative
|
The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned shim exhibited signs of wear and tear, suggesting repeated use.One of each of the springs and ball bearings was disassembled and not returned for evaluation.The device history records were reviewed and no discrepancies were identified.A previous investigation into this issue was initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.The device was subsequently re-designed to account for this failure mode with a new locking mechanism.This device was manufactured prior to the design modification and therefore the root cause is the previously addressed design issue.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
|
|
|