Model Number N/A |
Device Problem
Break (1069)
|
Patient Problem
Bone Fracture(s) (1870)
|
Event Date 06/05/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Report source: (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported by the hospital that a patient underwent revision due to a tibial plateau fracture.
|
|
Event Description
|
It was reported by the hospital that a patient underwent revision due to a tibial plateau fracture.
|
|
Manufacturer Narrative
|
Cmp-(b)(4).This follow-up report is being submitted to relay additional information.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.
|
|
Search Alerts/Recalls
|