BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE ECC HD 44X21

    MDR report key: 2052551 · Received April 11, 2011

    Report

    Report Number
    1818910-2011-06315
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWS
    PMA / PMN Number
    K992065
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORT FOR ALL OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO 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 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 AND LACK OF RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE ECC HD 44X21 KWS & HSD KWS DEPUY ORTHOPAEDICS, INC. NA CX2DB1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention