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

Catalog Number	154718
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D-10: 159540, oxf anat brg lt sm size 3 pma, lot 075460.161468, oxf twin-peg cmntd fem sm pma, lot 175740.110035368, biomet bc r 1x40 us, lot ay37aj2103.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.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.Two views of the left knee demonstrate a medial compartment hemi arthroplasty with loosening of the femoral and tibial components as well as narrowing suggesting polyethylene wear.Initially, lateral knee progression was reported, this cannot be confirmed based on the available information.However, the provided radiographs confirmed loosening of both the femoral and tibial components and suggested possible wear of the bearing.Despite these findings, 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.
Event or Problem Description
It was reported that the patient underwent revision of the left knee due to lateral progression two and a half years post implantation.Further review of radiographs received identified a medial compartment hemi arthroplasty with loosening of the femoral and tibial components as well as narrowing suggesting polyethylene wear.Attempts have been made and no further information has been provided.

• Brand Name: OXFORD UNI TIB TRAY SZA LM
• 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: 21729190
• Report Number: 3002806535-2025-00133
• Device Sequence Number: 12945323
• Product Code: NRA
• UDI-Device Identifier: 05019279388844
• UDI-Public: (01)05019279388844(17)301115(10)301190
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/31/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 154718
• Device Lot Number: 301190
• 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: 03/28/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female