MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG LT LG SIZE 3 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Catalog Number	159554
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ 161470, oxf twin-peg cmntd fem lg pma, lot 334580.154724, oxf uni tib tray sz d lm pma, lot 056790.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent revision surgery of the left knee ten years and six months post implantation due to a bearing fracture.No attempts have been made as all information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.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 history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Radiographs were provided and reviewed by a radiologist.The review identified a left knee medial unicompartmental arthroplasty with a fractured bearing, metal-on-metal implant contact, and knee varus.There is a fractured piece of the bearing within the suprapatellar recess as noted.No contributing factors for the poly fracture are identified on the images.Based on the available information, the reported event can be confirmed.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
No further event information available at the time of this report.

• Brand Name: OXFORD ANAT BRG LT LG SIZE 3 PMA
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• 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: 21750023
• Report Number: 3002806535-2025-00141
• Device Sequence Number: 10161601
• Product Code: NRA
• UDI-Device Identifier: 05019279786008
• UDI-Public: (01)05019279786008(17)190207(10)754100
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/07/2019
• Device Catalogue Number: 159554
• Device Lot Number: 754100
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2014
• 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: Male
• Patient Weight: 91 KG