Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problems
Failure of Implant (1924); No Code Available (3191)
|
Event Date 12/30/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Report source: foreign (b)(6).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 a patient had a total knee arthroplasty subsequently three years after the procedure the patient was scheduled for a right knee revision due to malfunctioning.During the implant removal, it was discovered that the tibial tray had fractured.
|
|
Manufacturer Narrative
|
(b)(4).Complaint is confirmed.Visual examination of the provided pictures identified that the tibial is broken.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.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
|