MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB TRAY SZ B RM PMA; KNEE PROSTHESIS

Catalog Number	154721
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Insufficient Information (4580); Aseptic loosening (4883)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf twin-peg cmntd fem sm pma; item# 161468; lot# 083130.Oxf anat brg rt sm size 5 pma; item# 159570; lot# 304230.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
It was reported that the patient had a right knee arthroplasty.Subsequently, approximately one year and ten months post implantation, they underwent a revision surgery due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a4, b1, b4, b5, b7, d10, g3, g6, h2, h6, h10, h11.D10 - associated medical devices: unknown cement; item# unknown; lot# unknown.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
It was reported that a patient had an initial right knee medial unicondylar arthroplasty performed.Subsequently, the patient was revised approximately one year and ten months later, due to pain felt to be secondary to end-stage arthritis of the knee.During the revision, the tibial component was found loosely fixed to the tibia and was easily removed.The femoral component was noted to sit in significant flexion relative to the distal femoral condyle.While removing the femoral component, a small nondisplaced fracture was noted at the distal medial condyle which extended distal to the mcl origin.No further fragment displacement occurred, and no additional treatment or intervention was required.The total knee arthroplasty was completed without further complications.Attempts have been made and no further event information is available at the time of this report.
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 information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, 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 histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Complaints are monitored per complaint trending process.Medical records were provided and reviewed by a health care professional.The review indicated extensive lateral compartment wear to full thickness and a tibial component exhibiting mild loosening.The component was inadequately fixed and was removed without difficulty.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.

• Brand Name: OXFORD UNI TIB TRAY SZ B RM 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: 22381685
• Report Number: 3002806535-2025-00245
• Device Sequence Number: 13157344
• Product Code: NRA
• UDI-Device Identifier: 05019279388875
• UDI-Public: (01)05019279388875(17)321006(10)405220
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 11/28/2025

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: 154721
• Device Lot Number: 405220
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 11/20/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/14/2025; 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 112 KG