MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; PROSTHESIS, KNEE

Catalog Number	161468
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery as the femoral component debonded from the bone and became loose, approximately six months post-operatively.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item name: oxf anat brg rt sm size 5 pma; item 159570; lot 66212655.D10: item name: oxf uni tib tray sz b rm pma; item 154721; lot 66829843.D10: item name: biomet bc r 2x20 us; item 1100353691; lot av26ah0103.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
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4, d9, g3, g6, h2, h3, h4, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.The reported cement was reviewed for compatibility with the femoral component, with no issues noted.The device history record was reviewed, and no discrepancies relevant to the reported event were found.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.A definitive root cause cannot be determined.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Common Device Name: PROSTHESIS, KNEE
• 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: 23629891
• Report Number: 3002806535-2025-00541
• Device Sequence Number: 9536891
• Product Code: NRA
• UDI-Device Identifier: 05019279438228
• UDI-Public: (01)05019279438228(17)341126(10)66972460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 04/08/2026

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: 161468
• Device Lot Number: 66972460
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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