BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX HV WITH GENTAMICIN US 1 PACK

    MDR report key: 9941573 · Received April 8, 2020

    Report

    Report Number
    0002249697-2020-00710
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    January 1, 2014
    Report Date
    April 8, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    UDI-DI
    04260056885761
    PMA / PMN Number
    K123081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORTING. SUPPLIER HAS BEEN NOTIFIED. SERIOUS INJURY REPORTS FOR HV PRODUCTS ARE ALSO FILED TO THE FDA VIA STRYKER PERSONNEL. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    MARCH 16, 2020: INFORMATION RECEIVED VIA OP REPORT INDICATES THAT THE PATIENT WAS IMPLANTED WITH COMPETITOR KNEE DEVICES WITH SIMPLEX HV CEMENT. THE PATIENT WAS LATER REVISED DUE TO INFECTION. IT'S REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY IN 2014 WHERE HE WAS IMPLANTED WITH A STRYKER KNEE SYSTEM. IS IT FURTHER ALLEGED THAT THE PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399191 SIMPLEX HV WITH GENTAMICIN US 1 PACK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH 6195-1-001 329BA878EU 04260056885761

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R