Model Number N/A |
Device Problem
Naturally Worn (2988)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 01/11/2024 |
Event Type
Injury
|
Event Description
|
It was reported that the patient underwent a revision procedure 31 years post implantation due to poly wear.There is no additional information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.H3 other text : device location is unknown.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint as no product information or medical records were provided.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.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
|
There is no update to the prior event description provided.
|
|
Search Alerts/Recalls
|