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

Catalog Number	159532
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 3 years and 10 months post initial implantation, the patient underwent a revision surgery due to tibial implant malpositioning.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf twin-peg cmntd fem xs pma; item# 161467; lot# 294660.Oxf anat brg rt x-sm 3mm pma; item# 160790; lot# 533750.Unknown cement; item# unknown; lot# unknown.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 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 that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.A radiograph was provided and reviewed by a radiologist.Single ap film of the bilateral knees demonstrates a right knee medial compartment hemiarthroplasty with possible medial position of the tibial component.Nonspecific cement extrusion noted along the medial aspect of the medial tibial plateau.Sizing is appropriate and no loosening is noted.Based on the available information, the reported event can be confirmed.However, due to the absence of medical records and additional radiographs, it is not possible to determine whether the implant was initially placed in the wrong position or if the malposition developed over time while in vivo.A definitive root cause could not be confirmed.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 AA 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 CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21605577
• Report Number: 3002806535-2025-00119
• Device Sequence Number: 8756907
• Product Code: NRA
• UDI-Device Identifier: 05019279783144
• UDI-Public: (01)05019279783144(17)291124(10)487840
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/13/2025

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: 159532
• Device Lot Number: 487840
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2019
• 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 Sex: Female