BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX HV WITH GENTAMICIN US 1 PACK

    MDR report key: 10799780 · Received November 6, 2020

    Report

    Report Number
    0002249697-2020-02353
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    August 19, 2019
    Report Date
    November 6, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    UDI-DI
    04260056885761
    PMA / PMN Number
    K123081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER ORTHOPAEDICS IS A DISTRIBUTOR OF THIS DEVICE, WHICH IS MANUFACTURED BY OSARTIS. THE MANUFACTURER HAS RESPONSIBILITY FOR REGULATORY DECISIONS AND MDR/MDV REPORTING. SUPPLIER HAS BEEN NOTIFIED. SERIOUS INJURY REPORTS FOR HV PRODUCTS ARE ALSO FILED TO THE FDA VIA STRYKER PERSONNEL. 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 · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2015 THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT WITH GENTAMICIN. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 HE HAD TO UNDERGO A REVISION SURGERY DUE TO LOOSE TIBIA AND MARKED INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263902 SIMPLEX HV WITH GENTAMICIN US 1 PACK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH 6195-1-001 442BA870DV 04260056885761

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R