Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/04/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that instrument fractured during cleaning.There is no additional information at this time.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
The reported event was confirmed as product was returned and visual evaluation of provisional stemmed tibial exhibits signs of repeated use and it is fractured into two pieces.Review of the device history records identified no deviations or anomalies.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.
|
|
Search Alerts/Recalls
|