Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).It is indicated that the product will not be returned to zimmer biomet for investigation, as no response has yet been received from the complainant.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It is reported that the patient underwent elbow arthroplasty revision to exchange the polyethylene bushings due to unknown reasons approximately seventeen (17) years post-operatively.Attempts have been made to retrieve additional information, but no further information is available at this time.
|
|
Manufacturer Narrative
|
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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history was unable to be performed, as the part number and lot number are unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
|