BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BC R 1X40 US

    MDR report key: 25270644 · Received May 25, 2026

    Report

    Report Number
    3006946279-2026-00026
    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 Y18AAD0605,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
    139369 BIOMET BC R 1X40 US BONE CEMENT LOD BIOMET FRANCE S.A.R.L. AZ50BA2102 00887868214578

    Patients

    Seq Age Sex Outcome Treatment
    1