MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ D RM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED

Catalog Number	166577
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision knee surgery due to a tibial plateau fracture.The surgeon stabilized the fracture with a plate and revised the prosthesis by replacing the uncemented tibial tray and bearing with a cemented tibial tray and a new bearing.The tibial tray was downsized from a size d to a size c, approximately 1 month and 4 days post-implantation.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).D10: oxf anat brg rt lg size 3 pma; item# 159582; lot# 7868812.Oxford ph3 cementless fem sz l; item# 154927; lot# 66370135.G2 ¿ foreign ¿ new zealand.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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: a1; a3a; b4; b5; d2a; g3; g6; 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 found no additional related complaints for this item.Radiographs were provided and reviewed by a radiologist.The review identified that the tibial component position is malpositioned, as it is abnormally rotated.A vertical fracture line extends distally from the keel, exiting at the medial tibial metadiaphyseal cortex.There is slight medial displacement of the medial tibial plateau containing fracture fragment.Radiolucency is present at the tibial component keel/plate metal bone interfaces is consistent with loosening of the tibial component.The reported event was confirmed by review of x-rays.A definitive root cause cannot be determined.However, according to the xray review, malpositioning of the tibial component may be a contributing factor.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.

• Brand Name: OXF UNI CMNTLS TIB SZ D RM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED
• 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: 22673302
• Report Number: 3002806535-2025-00295
• Device Sequence Number: 14377987
• Product Code: NRA
• UDI-Device Identifier: 00887868354762
• UDI-Public: (01)00887868354762(17)341015(10)66898239
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/02/2025

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 Catalogue Number: 166577
• Device Lot Number: 66898239
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male