|
Model Number N/A |
Device Problems
Material Erosion (1214); Unstable (1667)
|
Patient Problems
Failure of Implant (1924); Pain (1994); Scar Tissue (2060)
|
Event Date 02/14/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: 150476 - oss poly tibial bushing - 747290, 150478 - oss poly lock pin - 354510, 161035 - oss rs axle - 046410, 161034 - oss rs poly fem bushings set/2 - 511150, 150493 - oss tibial poly bearing - 683830.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 will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00595.
|
|
Event Description
|
It was reported that the patient had a left knee revision approximately 2.5 months post implantation due to implant fracture, pain, and instability.During the revision, scar tissue and wear were noted.The tibial bearing, bushing, rs axle, yoke, femoral bushings set and locking pin were exchanged without complications.Attempts have been made and no further information has been provided.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
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.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: complains of pain and instability, x-rays show flanges at the poly are broken; 2 weeks later office visit: pain and instability; revision op notes: noted asymmetric wear of the underside of the polyethylene, broken flanges on the tibial axle capture mechanism, no complications.A definitive root cause cannot 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
|
|
|