BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-LINK HIMO HUM CUP 42+3

    MDR report key: 3061937 · Received April 16, 2013

    Report

    Report Number
    1818910-2013-15447
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575
    Product Code
    KWS
    PMA / PMN Number
    PK091751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 ADDITIONAL REPORTS FOR THE GLENOSPHERE PART AND LOT NUMBER COMBINATION; ONE PREVIOUS REPORT FOR THE CUP PART AND LOT NUMBER COMBINATION BUT WAS NOT RELATED TO DISLOCATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX D. TERRITORY OFFICE COMMUNICATED NO ADDITIONAL INFORMATION IS AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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.

    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 DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162949 X-LINK HIMO HUM CUP 42+3 HUMERAL CUP KWS DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575 116061

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention