MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB TRAY SZ C LM PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Catalog Number	154722
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent conversion of a unicompartmental knee arthroplasty to a left total knee arthroplasty eight and a half years post implantation due to lateral disease.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: 159547, oxf anat brg lt md size 3 pma, lot 176290 161469, oxf twin-peg cmntd fem md pma, lot 737800.The products involved in the reported event were not returned for investigation; however, pictures were provided and reviewed.Photograph shows explanted components from an oxford knee system placed on a sterile drape following removal.The image appears to include the femoral component, tibial component, and polyethylene bearing, with residual biological material visible on the metallic surfaces.No additional information can be determined from the photograph alone.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Radiographs were provided and reviewed by a radiologist.The review identified, left knee medial compartment knee arthroplasty.Tibial tray exhibits medial overhang (possible oversizing).Suspect loosening of the tibial component.Relative paucity of cement underlying the medial aspect of the medial tibial tray and osteopenia may be risk factors for loosening.Heterotopic ossification adjacent to the polyethylene bearing.Moderate osteoarthritis lateral femorotibial joint compartment.Moderate-marked osteoarthritis of patellofemoral joint compartment.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.

• Brand Name: OXFORD UNI TIB TRAY SZ C LM PMA
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25298457
• Report Number: 3002806535-2026-00199
• Device Sequence Number: 13103369
• Product Code: NRA
• UDI-Device Identifier: 05019279388882
• UDI-Public: (01)05019279388882(17)261223(10)541930
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 154722
• Device Lot Number: 541930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 93 KG