MAUDE Adverse Event Report: Biomet UK Ltd. OXFORD UNI CMNTLS TIB SZ E LM; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained

Catalog Number	166578
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, approximately two months post-implantation, the patient underwent a revision surgery due to a tibial periprosthetic fracture.Due diligence is in progress for this complaint; no additional information or product has been received at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf twin peg cmntls fmrl lg; item# 161475; lot# 67443572.Oxf anat brg lt lg size 7 pma; item# 159558; lot# 733170.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.

• Brand Name: OXFORD UNI CMNTLS TIB SZ E LM
• Common Device Name: Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained
• 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 ; +1(574)526-0384
• MDR Report Key: 50406275
• Report Number: 3002806535-2026-00322
• Device Sequence Number: 9200637
• Product Code: NRA
• UDI-Device Identifier: 00887868354779
• UDI-Public: (01)00887868354779(17)350806(10)67313119
• 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: 2026
• Device Explanted Year: 2026
• 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): 08/24/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 166578
• Device Lot Number: 67313119
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 Narrative.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male