Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Bone Fracture(s) (1870)
|
Event Type
Injury
|
Manufacturer Narrative
|
Cmp-(b)(4).(b)(4).Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, the patient was experiencing implant fracture few months post-operative and is undergoing a conservative treatment.No revision occurred, implant remains in patient.
|
|
Manufacturer Narrative
|
(b)(4).This report is being submitted to relay additional information.Reported event has been confirmed by review of xrays received.Device history record (dhr) was reviewed with no deviations identified.The reported event is considered confirmed based on the review of the provided x-ray.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
|