MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED

Catalog Number	159547
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item name# oxf twin peg cmntls fmrl md; item number# 161474; lot # 67236421.Item name# oxf uni cmntls tib sz c lm; item number# 166574; lot # 67253476.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 underwent a total knee arthroplasty revision due to polyethylene insert dislocation.Approximately 1 month and 20 days post-implantation.Attempts have been made, and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h3, h4, h6, h11.The reported event was confirmed by review of radiographs.No product was returned or pictures provided; a product evaluation could not be performed.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 review of the device manufacturing records identified the following non-conformance (ncr)/deviation that could be related to the reported event.Radiographs were provided and reviewed by a radiologist.The review of the ap and lateral knee views demonstrated postoperative changes consistent with medial unicompartmental arthroplasty.Dislocation of the polyethylene component was identified, with the component displaced and vertically rotated within the medial gutter, deep to the mcl.Impression: medial compartment knee arthroplasty with dislocation of the polyethylene component.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.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24001434
• Report Number: 3002806535-2026-00007
• Device Sequence Number: 10184865
• Product Code: NRA
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 159547
• Device Lot Number: 67299609
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown