It was reported that the patient underwent an initial right unilateral (medial side) partial knee replacement.Subsequently, was revised to a total knee six months later due to pain, difficulty with ambulation, and extensive radiolucency along the tibial implant which appears loose and subsided laterally.There is also suspected lucency along the femoral implant without frank loosening.Bone quality is markedly osteopenic.Due diligence is in progress for this complaint; to date no additional information or product has been received.
|
(b)(4).Oxf uni tib tray sz c rm pma, item# 154723, lot# 65717233; oxf anat brg rt sm size 3 pma, item# 159568, lot# 164880; unknown cement, item# unknown, lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00235; 3002806535-2023-00236.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.
|
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.Device/s are used for treatment.Radiographs were provided and reviewed by a radiologist.Medial unicompartmental arthroplasty with tibial implant loosening and lateral subsidence.Marked osteopenia.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.
|