BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX HV US 1 PACK

    MDR report key: 12587257 · Received October 6, 2021

    Report

    Report Number
    0002249697-2021-01679
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 6, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    UDI-DI
    04260056885747
    PMA / PMN Number
    K123225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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/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

    DR. REVISED A RIGHT MAKO MEDIAL UNI TO A TOTAL KNEE TRIATHLON DUE TO PAIN. NO EVIDENCE OF LOOSENING OR ALLEGATIONS AGAINST THE COMPONENTS. UPDATE 10/SEPTEMBER/2021 WG: REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION IS DUE TO HOSPITAL POLICY. REVISION SURGERY WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484684 SIMPLEX HV US 1 PACK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH 6194-1-001 925AB939EA 04260056885747

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R