MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 7 PMA; KNEE PROSTHESIS

Catalog Number	159579
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ item 154719; oxf uni tib tray sza rm; lot: 7182178.Item 166942; oxford uni twin-peg femoral md; lot: j71788899.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 had an initial knee arthroplasty.Subsequently, they underwent a revision surgery due to instability, approximately 3 years, 3 months postoperatively.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.No products were returned or pictures provided; a product evaluation could not 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 thereported part and lot combinations.Radiographs were provided and reviewed by a health care radiologist.The review identified a photograph of computer screen of anteroposterior view of the right knee showing a unicompartmental arthroplasty of the knee involving the medial compartment.Thin radiolucency (less than 1 mm) at the bone cement interface around the tibial component is marked by arrows on the image.Mild osteoarthritis is noted in the lateral compartment in the form of osteophyte formation without joint space narrowing.There appears to be relative valgus alignment of the knee components, however a standing bone length view of the extremities would be necessary to provide definitive measurements.Unicompartmental arthroplasty of the left knee.Thin radiolucency at the bone cement interface around the tibial component is indeterminate for loosening and may represent fibrous ingrowth-comparison with prior radiographs would be helpful for comparison to evaluate for change over time.No other signs of loosening or acute hardware complication are identified.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 available at the time of this report.

• Brand Name: OXF ANAT BRG RT MD SIZE 7 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: 23632775
• Report Number: 3002806535-2025-00547
• Device Sequence Number: 15775596
• Product Code: NRA
• UDI-Device Identifier: 05019279786251
• UDI-Public: (01)05019279786251(17)251009(10)6876415
• 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: 2022
• 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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/09/2025
• Device Catalogue Number: 159579
• Device Lot Number: 6876412
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2020
• 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: 71 YR
• Patient Sex: Female