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

Catalog Number	159568
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item name: oxf twin-peg cmntd fem sm pma; item number: 161468; lot number: 612200.Item name: oxf uni tib tray sza rm; item number: 154719; lot: 441610.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 revision surgery due to an unknown reason.Approximately 7 years and 10 months post-implantation.Attempts have been made and all additional information received has been included in this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d1, d10, g3, g6, h1, h2, h3, h6, h11.The following section was corrected: b2.D -10 unknown cement, lot unknown.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.Review of the complaint history identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Based on the available information, the reported event cannot be confirmed.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.

• 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 CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21227992
• Report Number: 3002806535-2025-00011
• Device Sequence Number: 15338881
• Product Code: NRA
• UDI-Device Identifier: 05019279786145
• UDI-Public: (01)05019279786145(17)200709(10)521360
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/04/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: 159568
• Device Lot Number: 521360
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2015
• 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 H10 NARRATIVE; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Female