BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KNEE

    MDR report key: 18062403 · Received November 2, 2023

    Report

    Report Number
    0002249697-2023-01321
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    October 10, 2023
    Report Date
    November 2, 2023
    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 STRYKER FACEBOOK PAGE: "I HAD A STRYKER KNEE REPLACEMENT IN 2005, 18 YEARS LATER AND DOING GREAT,I HAD A POLY EXCHANGE ON IT IN MARCH, CUT OPEN ON SAME SCAR,23 STAPLES IN CASE HE HAD TO REPLACE WHOLE THING BUT ALL WAS GOOD EXCEPT RESIN PIECE UNDER PATELLA. BACK WORKING 2 WEEKS LATER. STRYKER IS THE BEST AND MY SURGEON WAS THE BEST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025925 UNKNOWN_KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H