MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 PMA; KNEE PROSTHESIS

Catalog Number	159555
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Item name: unknown femoral component; item number: unknown; lot: unknown item name: unknown tibia component; item number: unknown; lot: unknown item name: unknown bone cement; item number: unknown; lot: unknown 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 knee revision surgery due to bearing poly swap, approximately 10 years and 3 months post-implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).The following sections were updated: b4, b5, d4, g1-2, g3, g6, h2, h3, h4, h6, h11.Corrections: d4, g1-2, h4.No product was returned for investigation, but pictures of the bearing were provided.The pictures show that the surface of the bearing is worn and scratched.A review of the device manufacturing records confirmed no abnormalities or deviations.A review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Four radiographs were provided and reviewed by a radiologist.There is a medial unicompartmental arthroplasty of the left knee.There is no fracture or implant loosening.The implants are anatomically aligned, but there is evidence of severe liner wear and suspected metal-on-metal implant contact.Bone quality is markedly osteopenic.A definitive root cause cannot be established.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 LT LG SIZE 4 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: 21397593
• Report Number: 3002806535-2025-00032
• Device Sequence Number: 7898967
• Product Code: NRA
• UDI-Device Identifier: 05019279786015
• UDI-Public: (01)05019279786015(17)190331(10)585370
• 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: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 03/31/2019
• Device Catalogue Number: 159555
• Device Lot Number: 585370
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2014
• 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: 81 KG