BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL AP PC STEM 10 MM

    MDR report key: 6001135 · Received October 5, 2016

    Report

    Report Number
    1818910-2016-28796
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 22, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWS
    PMA / PMN Number
    K063652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HUMERAL STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652337 GLOBAL AP PC STEM 10 MM SHOULDER HUMERAL STEM/EPIPHYSIS KWS DEPUY ORTHOPAEDICS, INC. 1818910 257515

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention