MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG LT MD SIZE 5 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Catalog Number	159549
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 166574, oxf uni cmntls tib sz c lm, lot 7375563.154926, oxford ph3 cementless fem sz m, lot 7666992.G2: foreign - event occurred in 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 a patient had an initial left medial unicondylar knee arthroplasty performed one and a half year ago.Subsequently, the patient had sustained a fall due to unknown reasons and required a poly exchange seventeen months post implantation due to instability, pain, and inability to straighten the knee, indicating the poly had likely rotated and locked his knee.The poly was upsized during the revision with no further complications reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product involved in the reported event was not returned for investigation; however, pictures were provided and reviewed.Visual examination of the provided picture identified scratches and gouges on the surface of the bearing.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.The reported event was confirmed by review of x-rays.Radiographs were provided and reviewed by a radiologist.The review identified three radiographic views of the left knee (unknown date) showed presence of left medial unicondylar knee arthroplasty components.The knee was flexed, which limits assessment of metal bone interfaces and component alignment on the ap view.On lateral view, sagittal, femoral component alignment is standard, and excessive posterior slope of the tibial component (approximately 14 degrees) is demonstrated.The radiolucent bearing, with its associated linear metallic bearing marker, is dislocated out of the artificial medial joint compartment and seen to be residing peripheral to the anteromedial joint line.There is metal-on-metal contact of the femoral component with the tibial component and varus anatomic alignment of the knee.Excessive posterior slope of the tibial component may be a risk factor for bearing dislocation.A definitive root cause cannot 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 available at the time of this report.

• Brand Name: OXFORD ANAT BRG LT MD SIZE 5 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23714667
• Report Number: 3002806535-2025-00560
• Device Sequence Number: 8910411
• Product Code: NRA
• UDI-Device Identifier: 05019279785957
• UDI-Public: (01)05019279785957(17)280205(10)7444238
• 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: 2024
• 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): 03/06/2026

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: 159549
• Device Lot Number: 7444238
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2023
• 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: 46 YR
• Patient Sex: Male