MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT MD SIZE 8 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Catalog Number	159580
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ 154926, oxford ph3 cementless fem sz m, lot 7398998, 166575, oxf uni cmntls tib sz c rm, lot 7206827, g2 ¿ foreign ¿ australia.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 underwent revision surgery on the right knee one-and-a-half-year post implantation due to bearing dislocation.Only bearing was revised.No additional information is available.
Additional Manufacturer Narrative
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 for investigation.Two pictures of the bearing were provided, but due to the low quality, a visual assessment cannot 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.Three radiographs were provided and assessed.There is a medial unicompartmental arthroplasty of the right knee.On the ap standing view of both knees, the right knee components are anatomically aligned and without abnormality.On the additional ap view and lateral view, there is malalignment of the tibial implant with subsidence and anterior displacement of the polyethylene liner.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
Malalignment of the tibial implant with subsidence and loosening and anterior displacement of the polyethylene liner were identified on the additional ap view and lateral view.

• Brand Name: OXFORD ANAT BRG RT MD SIZE 8 PMA
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• 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: 22192344
• Report Number: 3002806535-2025-00233
• Device Sequence Number: 18352028
• Product Code: NRA
• UDI-Device Identifier: 05019279786268
• UDI-Public: (01)05019279786268(17)250227(10)6748951
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 02/27/2025
• Device Catalogue Number: 159580
• Device Lot Number: 6748951
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 92 KG