(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device whereabouts are unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: 42521400811 articular surface fixed bearing posterior stabilized right 11 mm lot# 63378992 mdr: 0002648920-2020-00541.42532007502 tibia cemented 5 degree stemmed right size f lot# 63603170 mdr: 3007963827-2020-00336.
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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.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: therapy performed due to pain, instability, weakness, use of assistive device, performed thereafter for left tka and right knee ongoing pain, patient has 3/5 mmt for knee extension/flexion; patient has crepitus around knee, limp right leg, failed conservative therapy treatment, adhesion/scar tissue removal, instability and pain that implant adl, very thickened black synovium consistent with metallosis, metal stained synovium, tibial insert had disengaged from tray, burnishing of posterior condyles consistent with metal wear, tibial tray showed significant wear with locking mechanism destroyed, removed femoral and tibial components, debridement of metal stained synovium, patella and patella component well fixed and tracked well.Complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
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