MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI CMNTLS TIB SZ C RM; KNEE PROSTHESIS

Catalog Number	166575
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Aseptic loosening (4883); Periprosthetic fracture (4902)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Approximately ten weeks post-implantation, the patient required a revision surgery due to a tibial bone fracture, which was attributed to the loosening of the tibial implant.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxford ph3 cementless fem sz m; item# 154926; lot# 7836870.Oxf anat brg rt md size 4 pma; item# 159576; lot# 7667282.G2 - foreign: japan.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
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, 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.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Radiographs were provided and reviewed.The review assessed 4 images for radiology review.2 images are pre-uni knee implant, and the 2 set of images are 4 days post implant.The complaint is for jun revision for loosening and fracture.Submitting images that are 4 days post implant without sequel images would not provide significant findings.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 is available at the time of this report.

• Brand Name: OXFORD UNI CMNTLS TIB SZ C RM
• 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: 22413320
• Report Number: 3002806535-2025-00248
• Device Sequence Number: 8407428
• Product Code: NRA
• UDI-Device Identifier: 00887868354748
• UDI-Public: (01)00887868354748(17)341023(10)66853423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/04/2025

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: 166575
• Device Lot Number: 66853423
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Female