BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BC R 1X40 US

    MDR report key: 25270578 · Received May 25, 2026

    Report

    Report Number
    3006946279-2026-00025
    Event Type
    Injury
    Date Received
    May 25, 2026
    Report Date
    May 25, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00887868214578
    PMA / PMN Number
    K172408
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110036368, LOT: AZ50BA2102, BIOMET BC R 1X40 US. 141232, BIOMET CC CRUCIATE TRAY 67MM, LOT: J7548277. 183006, VANGUARD CR ILOK FEM-RT 62.5, LOT: J7615026. 183422, VNGD CR TIB BRG 12X63/67, LOT: 65860478. 11-150825, BMET ARCOM AP PAT W/WIRE 28MM, LOT: 66776976. 414-702, CLEARMIX SINGLE/DOUBLE 10PK, LOT: 32565. 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 THE PATIENT DEVELOPED PAIN AND SUFFERING AND MECHANICAL SYMPTOMS IN THE RIGHT KNEE FOLLOWING A TOTAL KNEE ARTHROPLASTY. NO INTERVENTION HAS BEEN REPORTED TO DATE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554274 BIOMET BC R 1X40 US BONE CEMENT LOD BIOMET FRANCE S.A.R.L. Y18AAD0605 00887868214578

    Patients

    Seq Age Sex Outcome Treatment
    1