MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT X-SM 4MM PMA; KNEE PROSTHESIS

Catalog Number	160791
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bearing was implanted after intraoperative straightening and flexion gap adjustments had been balanced.However, as the procedure was still ongoing, rotation of the bearing occurred.Upon removal, wear was observed on the bearing¿s anti-rotation angle.The procedure was completed using an alternative bearing without any complications.Due diligence is in progress for this complaint; no further additional information or product has been received at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: unknown oxford femoral component; item# unknown; lot# unknown.Unknown oxford tibial component; item# unknown; lot# unknown.G2 - foreign: china.Investigation of this incident is currently ongoing.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 information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Visual examination of the product returned shows that signs of use with visible gouges on articular surface and outer profile.Further inspection found scratches on the distal surface.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.Complaints are monitored per complaint trending process.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
No further event information is available at the time of this report.

• Brand Name: OXFORD ANAT BRG RT X-SM 4MM 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: 22028881
• Report Number: 3002806535-2025-00196
• Device Sequence Number: 15557266
• Product Code: NRA
• UDI-Device Identifier: 05019279073023
• UDI-Public: (01)05019279073023(17)280925(10)7596386
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 160791
• Device Lot Number: 7596386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown