BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX HV WITH GENTAMICIN US 1 PACK

    MDR report key: 10799785 · Received November 6, 2020

    Report

    Report Number
    0002249697-2020-02347
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    January 16, 2020
    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

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. STRYKER ORTHOPAEDICS IS A DISTRIBUTOR OF THIS DEVICE, WHICH IS MANUFACTURED BY AAP. 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.

    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) 2017 THE PATIENT UNDERWENT A RIGHT SIDED TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT WITH GENTAMICIN AND TRIATHLON KNEE SYSTEM. IT IS FURTHER ALLEGED THAT ON (B)(6) 2020 SHE HAD TO UNDERGO A REVISION SURGERY DUE TO MECHANICAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264377 SIMPLEX HV WITH GENTAMICIN US 1 PACK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH 6195-1-001 701BA993MX 04260056885761

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R