BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 80 REFOB BONE CMT R-3

    MDR report key: 23165500 · Received September 29, 2025

    Report

    Report Number
    MW5176647
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    June 17, 2024
    Report Date
    September 23, 2025
    Manufacturer
    BIOMET FRANCE
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-SYNTHES PRODUCT. CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE KNEE PAIN. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: PROBABLY. PROCEDURE RELATED: PROBABLY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218724 OPTIPAC 80 REFOB BONE CMT R-3 BONE CEMENT LOD BIOMET FRANCE AZ28BE2801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown