Catalog Number 159576 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 01/17/2024 |
Event Type
Injury
|
Event Description
|
It was reported that three years and two months post initial implantation, the patient underwent a revision surgery due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
|
|
Manufacturer Narrative
|
(b)(4).D10 - associated medical devices: oxf twin-peg cmntd fem md pma; item# 161469; lot# 805270.Oxf uni tib tray sza rm; item# 154719; lot# 797490.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00051.3002806535-2024-00052.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
|
|
Event Description
|
It was reported that three years and two months post initial implantation, the patient underwent a revision surgery due arthritis progression to lateral compartment in addition to there being slight subsidence of the tibial baseplate.No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).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.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|