Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports have been filed for this event, please see associated reports 0001825034 - 2024 - 00796; 0001825034 - 2024 - 00797; 0001825034 - 2024 - 00799.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.
|
|
Event Description
|
It was reported that the patient is being considered for a revision procedure due to unknown reasons.There is no additional information available at the time of this report.
|
|
Event Description
|
There is no update to the prior event description provided.
|
|
Manufacturer Narrative
|
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Xray reviewed and not submitted to mmi for assessment at this time, image is undated so would be difficult to correlate to an allegation.Also single a/p image is of bilateral prosthesis and laterality has not been determined.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.
|
|
Search Alerts/Recalls
|