Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that patient is being considered for removal of shell component on an unknown date for an unknown reason.No surgery has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
|
|
Event Description
|
Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.
|
|
Search Alerts/Recalls
|