Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problem
Pain (1994)
|
Event Date 07/27/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).D10: medical product: oxf twin-peg cmntd fem sm pma; catalog no.: 161468; lot no.: 767490.Medical product: oxf uni tib tray sz aa rm pma; catalog no.: 159532; lot no.: 485700.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00272, 3002806535-2023-00274.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 patient underwent knee prostheses implantation approximately six (6) years ago.About six (6) years later patient complained of knee pain, resulting in revision surgery with exchanging knee prostheses.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
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00272-1, 3002806535-2023-00274-1.This follow-up report is being submitted to relay additional and/or corrected 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.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.Medial unicompartmental arthroplasty is present.There is radiolucency along the tibial and to a lesser degree femoral implants consistent with osteolysis.There is no implant displacement.There is suspected loosening of the tibial implant but no prior imaging is available for comparison to confirm this.Bone quality is osteopenic.With the available information, 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
|