BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KNEE

    MDR report key: 18586110 · Received January 26, 2024

    Report

    Report Number
    0002249697-2024-00138
    Event Type
    Injury
    Date Received
    January 26, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 26, 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. H3 OTHER TEXT : NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE STRYKER FACEBOOK PAGE, "I HAD MAKO ON MY KNEE REPLACEMENT ON (B)(6) 2023. I¿M STILL IN PT 3DAYS A WEEK. I HAD AND HAVE LOTS OF SWELLING AND I CAN¿T TAKE NSAID¿S DUE TO ULCERATIVE COLITIS(WHICH IS CONTROLLED THROUGH MY DIET). DR. DIDN¿T TELL ME THE PROTOCOL WAS NSAID¿S AFTER SURGERY TO REDUCE SWELLING. HE PUT ME ON A 6 DAY COURSE OF STEROIDS 2 DAYS BEFORE THANKSGIVING. IT DID HELP AND FINALLY ON DEC 10TH IS WHEN I WAS STARTING TO WALK BETTER AND I FELT I DIDN¿T HAVE PAIN 24/7. NOW I¿M JUST HOPING TO GET ALL MY MOTION BACK. WHEN THE WEATHER CHANGES OR IT RAINS¿. THE STIFFNESS IS HORRIBLE!! BUT I¿M NOT GIVING UP, I¿M GOING TO CONTINUE PT FOR AS LONG AS THEY LET ME. I DO NEED MY OTHER KNEE DONE IN THE FUTURE BUT DON¿T KNOW IF THAT WILL EVER HAPPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120917 UNKNOWN_KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other