MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG RT SM SIZE 3 PMA; KNEE PROSTHESIS

Catalog Number	159568
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Synovitis (2094); Osteolysis (2377)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf uni tib tray sz c rm pma; item# 154723; lot# 469410.Oxf twin-peg cmntd fem sm pma; item# 161468; lot# 681330.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient had an initial right knee arthroplasty.Subsequently, approximately eight years and five months post implantation, the patient underwent a revision due to poly wear and osteolysis.Due diligence is in progress for this complaint; no additional information or product has been received at the time of this report.
Event or Problem Description
It was reported that an initial right partial knee arthroplasty was performed.Subsequently, the patient has been revised and converted to a total knee arthroplasty, approximately eight years and five months post-implantation, due to poly wear and osteolysis.Intra-operative findings also included synovitis and cyst demonstrated on imaging.No complications were reported.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, b7, g3, g6, h2, h6, h11.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a2, b4, b5, g3, g6, h2, h3, h6, h11.The products involved in the reported event were returned for investigation: a visual inspection of the bearing shows wear on the distal tibial face with two deep grooves as well as pitting and scratches, the femoral face has a deep rounded grove worn into the femoral face and part of the land area.The returned tibial tray and femoral component both have bone cement adhered to the back faces and signs of expected wear, scratches and lines on the bearing faces.A review of the device manufacturing records confirmed no abnormalities or deviations.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.Complaints are monitored per complaint trending process.Medical records were provided and reviewed by a health care professional.The review identified the patient underwent revision surgery and was converted to a total knee arthroplasty due to polyethylene wear and associated osteolysis.Intra-operative findings included synovitis and a cyst.The contributing factors for these findings remain unknown.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 SM SIZE 3 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22609209
• Report Number: 3002806535-2025-00281
• Device Sequence Number: 21358693
• Product Code: NRA
• UDI-Device Identifier: 05019279786145
• UDI-Public: (01)05019279786145(17)211226(10)374220
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup
• Report Date (Section B): 11/28/2025

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: 12/26/2021
• Device Catalogue Number: 159568
• Device Lot Number: 374220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 11/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/19/2025; 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2016
• 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
• Patient Weight: 73 KG