BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KNEE

    MDR report key: 18500479 · Received January 12, 2024

    Report

    Report Number
    0002249697-2024-00070
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 12, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE STRYKER FACEBOOK PAGE, "I TOTALLY AGREE WITH YOU!!! MY PAIN IS SO MUCH WORSE, DON¿T DO IT. THE DR SHOULD HAVE TO PAY FOR MONTHLY MASSAGES TO HELP WITH THE PAIN A LITTLE. THEY SWEAR TO YOU THAT THE PAIN LEAVES, NO WAY, JUST DON¿T DO IT!!!!" ADDITIONAL FACEBOOK COMMENT RECEIVED, "HAPPENED TO ME, BODY REJECTED THE REPLACEMENT AND GOT ALL INFECTED, HAD TO HAVE THE SURGERY REPEATED. IT WAS A VERY PAINFUL, HURTFUL TIME IN MY LIFE. MY KNEE HAS NEVER FULLY RECOVERED. I HAVE PAIN TO THIS DAY. I¿M NOT TRYING TO UPSET PEOPLE, I¿M SIMPLY BEING AS HONEST AND TRUTHFUL AS I CAN. MY PAIN IS WORSE THAN BEFORE THE SURGERY. GOD BLESS YOU AND GOOD LUCK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818094 UNKNOWN_KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other