BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BONE CEMENT R

    MDR report key: 23598008 · Received November 19, 2025

    Report

    Report Number
    MW5179086
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 2, 2023
    Report Date
    November 16, 2025
    Manufacturer
    BIOMET FRANCE
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A PARTIAL KNEE REPLACEMENT ON (B)(6) 2023. SYMPTOMS DEVELOPED A FEW MONTHS LATER, INCLUDING PAIN, DEFORMITY, LIMITED RANGE OF MOTION, WEAKNESS AND INSTABILITY. A COMPUTED TOMOGRAPHY SCAN DONE IN (B)(6) 2024 SHOWED LUCENCY AT THE TIBIAL AND FEMORAL BONE INTERFACE. BLOODWORK WAS DONE TO RULE OUT INFECTION. REVISION SURGERY TO A TOTAL KNEE REPLACEMENT WAS DONE ON (B)(6) 2024, WHERE "SIGNIFICANT POLY WEAR AND GROSS LOOSENING OF HER TIBIAL IMPLANT" WAS NOTED, ALONG WITH BEING "ANTERIOR CRUCIATE LIGAMENT DEFICIENT" AND HAVING "FULL THICKNESS CARTILAGE LOSS IN THE REMAINING COMPARTMENTS". A COMPUTED TOMOGRAPHY SCAN DONE A YEAR EARLIER, ON (B)(6) 2023 SHOWED ONLY A "MILD DEGREE OF DEGENERATIVE OSTEOARTHRITIS PRESENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314745 BIOMET BONE CEMENT R BONE CEMENT LOD BIOMET FRANCE 1X40 US AW05BB0603

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| O