MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG LT SM SIZE 3 PMA; KNEE PROSTHESIS

Catalog Number	159540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision of a prior medial unicompartmental left knee replacement performed approximately six months earlier for a fracture unrelated to the prosthesis.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 154925, oxford ph3, cementless fem sz s, lot 66946812.166572, oxf uni cmntls tib sz b lm, lot 66853374.G2: foreign - event occurred in australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, h11.The reported event could not be confirmed due to lack of product/information.The products involved in the reported event were not returned for investigation; however, pictures were provided and reviewed.The images show the explanted implants with residual bone and blood present.No fractures or visible damage were observed on the implants.In addition, the implant stickers were provided, which allow confirmation of the corresponding item and lot numbers.However, based only on the images submitted, it is not possible to perform a more detailed product evaluation.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.A definitive root cause cannot be determined, however the complaint description does state that the revision has been performed for a fracture unrelated to the prosthesis used.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 SM SIZE 3 PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24220355
• Report Number: 3002806535-2026-00042
• Device Sequence Number: 15475140
• Product Code: NRA
• UDI-Device Identifier: 05019279785865
• UDI-Public: (01)05019279785865(17)300408(10)7923208
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: 159540
• Device Lot Number: 7923208
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown