Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Bone Fracture(s) (1870)
|
Event Date 06/25/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that a patient underwent an initial left knee procedure.Subsequently, the patient was revised due to tibial plateau fracture.
|
|
Manufacturer Narrative
|
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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
|
It was reported that a patient underwent an initial left knee procedure.Subsequently, the patient was revised due to tibial plateau fracture.
|
|
Search Alerts/Recalls
|