BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE CTA HD 48X23

    MDR report key: 1914160 · Received December 1, 2010

    Report

    Report Number
    1818910-2010-09322
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSD
    PMA / PMN Number
    K000575
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFO STATES THE SURGEON REMOVED A 14 MM GLOBAL STEM AND A 48 X 23 CTA HEAD AND IMPLANTED A COMPETITIVE REVERSE SHOULDER. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE CTA HD 48X23 87HSD; 87KWS HSD DEPUY ORTHOPAEDICS, INC. NA BN3DJ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention