MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT X-SM 3MM PMA; KNEE PROSTHESIS

Catalog Number	160790
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent knee revision surgery due to pain, and the diagnosis confirmed that the right bearing had dislocated.The bearing and tibial plate were replaced, although the tibial plate was not loose.Approximately 8 years and 11 months post-implantation.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).D10: item name: oxford uni twin-peg femoral xs; item number: 166940; lot# j3676246.Item name: oxf uni tib tray sz aa rm pma; item number: 159532; lot# 3586284.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 and/or corrected 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.Ap and lateral radiographs of the right knee were reviewed by a radiologist.Findings confirm the presence of a medial unicompartmental knee arthroplasty.There is lateral displacement of the mobile bearing, with associated malalignment and lateral subluxation of the tibial component relative to the femoral component.No fracture or radiographic evidence of implant loosening is observed.Despite the subluxation, the overall implant fit appears appropriate, and the components are well-positioned radiographically.No abnormal radiolucency is seen around the implants.Bearing wear cannot be excluded based on radiographs alone.A definitive root cause cannot be established.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: OXF ANAT BRG RT X-SM 3MM 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: 21617108
• Report Number: 3002806535-2025-00122
• Device Sequence Number: 12436627
• Product Code: NRA
• UDI-Device Identifier: 05019279073016
• UDI-Public: (01)05019279073016(17)200805(10)3621094
• 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: 2016
• 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): 06/12/2025

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 Expiration Date: 08/05/2020
• Device Catalogue Number: 160790
• Device Lot Number: 3621094
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2015
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown