MAUDE Adverse Event Report: Biomet UK Ltd. OXF ANAT BRG RT MD SIZE 5 PMA; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained

Catalog Number	159577
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced persistent pain following implantation and expressed concern that the implanted partial device and associated instruments were subject to a recall.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: item name# oxf uni tib tray sz c rm pma; item number# 154723; lot number# 626160, item name# oxf twin-peg cmntd fem md pma; item number# 161469; lot number# 291940, item name# palacos r 1x40 single; item number# 00-1112-140-01; lot number# 84924545.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: OXF ANAT BRG RT MD SIZE 5 PMA
• 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: 50865530
• Report Number: 3002806535-2026-00345
• Device Sequence Number: 18814082
• Product Code: NRA
• UDI-Device Identifier: 05019279786237
• UDI-Public: (01)05019279786237(17)200421(10)799730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Expiration Date: 04/21/2020
• Device Catalogue Number: 159577
• Device Lot Number: 799730
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 narrative
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 255 LB