BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT BASIC CEMENTED SZ 2

    MDR report key: 3010399 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-14046
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. 3
    Product Code
    JDI
    PMA / PMN Number
    PK023453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE CEMENT/IMPLANT INTERFACE AFTER PATIENT DISLOCATED. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113950 SUMMIT BASIC CEMENTED SZ 2 FEMORAL HIP STEM JDI JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. 3 D12011067

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention