BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BONE CEMENT R 2X40G

    MDR report key: 24398750 · Received February 20, 2026

    Report

    Report Number
    3006946279-2026-00008
    Event Type
    Injury
    Date Received
    February 20, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    07350023774130
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3 : EVENT DATE : JULY 2022. D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D6B: JULY 2022. D10: (B)(6) - FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F LEFT - LOT 63487609. (B)(6) - ARTICULAR SURFACE SIZE EF 10 MM HEIGHT ''USE WITH PLATE 5 - LOT 63459803. (B)(6) - STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 5 FOR CEMENTED USE ONLY - LOT 63314083. (B)(6) - ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS - LOT 63426272. G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A LEFT INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT HAD BEEN EXPERIENCING POST-OP PAIN AND MOBILITY ISSUES NOTING THAT WAS UNABLE TO NOT WALK. A CT SCAN REVEALED THAT THE KNEE REPLACEMENT WAS DEFECTIVE AND THE PATIENT WAS SUBSEQUENTLY REVISED SIX YEARS LATER. THE ORIGINAL SYSTEM WAS REMOVED AND A NEW ONE WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391961 REFOBACIN BONE CEMENT R 2X40G BONE CEMENT MBB BIOMET FRANCE S.A.R.L. A552CK1626 07350023774130

    Patients

    Seq Age Sex Outcome Treatment
    1