BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_INSERT

    MDR report key: 20521608 · Received October 24, 2024

    Report

    Report Number
    0002249697-2024-01458
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 24, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MRH TIB ROT COMP XS-XL; CAT# 64812100; LOT# 211520 GMRS DIST FEM COMP STD L 65MM; CAT# 64952030; LOT# YJN4S UNKNOWN_TIBIAL PLATE; CAT# UNK_LIM; LOT# NOT REPORTED UNKNOWN_FEMORAL STEM; CAT# UNK_LIM; LOT# NOT REPORTED UNKNOWN_TIBIAL STEM; CAT# UNK_LIM; LOT# NOT REPORTED IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PERIPROSTHETIC INFECTION AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322032 UNKNOWN_INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Hospitalization| R