BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE CTA HD 52X18

    MDR report key: 2172617 · Received July 19, 2011

    Report

    Report Number
    1818910-2011-13306
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    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 AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE STEM PART AND LOT NUMBER COMBINATION. A SEARCH OF THE COMPLAINT DATABASE FOUND ONE PRIOR REPORTS FOR THE HEAD PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, DISCOMFORT, AND LACK OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE CTA HD 52X18 87HSD; 87KWS HSD DEPUY ORTHOPAEDICS, INC. NA D5SKH1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention