BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SIMPLEX GHV BONE CEMENT

    MDR report key: 12539400 · Received September 28, 2021

    Report

    Report Number
    0002249697-2021-01632
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    December 5, 2019
    Report Date
    September 28, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. 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. STRYKER ORTHOPAEDICS IS A DISTRIBUTOR OF THIS DEVICE, WHICH IS MANUFACTURED BY OSARTIS. THE MANUFACTURER HAS RESPONSIBILITY FOR REGULATORY DECISIONS AND MDR REPORTING. SUPPLIER HAS BEEN NOTIFIED. SERIOUS INJURY REPORTS FOR HV PRODUCTS ARE ALSO FILED TO THE FDA VIA STRYKER PERSONNEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A TKA AND DURING THE PROCEDURE SIMPLEX GHV BONE CEMENT WAS UTILIZED TO CEMENT ALL COMPONENTS IN PATIENT'S KNEE. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY AND THE TIBIAL COMPONENT WAS "COMPLETELY LOOSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438303 UNKNOWN_SIMPLEX GHV BONE CEMENT BONE CEMENT, ANTIBIOTIC MBB STRYKER ORTHOPAEDICS-MAHWAH 719AA857CY

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R