Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 12/27/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00114; 0001825034 - 2024 - 00112.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.
|
|
Event Description
|
It was reported that the patient underwent a revision procedure due to cup loosening.The acetabular cup, polyethylene liner and two screws were removed and replaced with a new acetabular cup and two augments.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
|
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the shell and liner are covered in bio-debris, no damage can be seen.One of the screws is fractured at the start of the threads.It is unknown if the screw was fractured in-vivo or during explanation.Complaint confirmed based on the evaluation of the provided images of the explanted products.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.
|
|
Search Alerts/Recalls
|