BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND GLENOSPHERE ECC D38MM

    MDR report key: 3102792 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-16831
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 1, 2013
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST
    Product Code
    KWS
    PMA / PMN Number
    PK062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFORMATION STATES THE DISCOMFORT WAS DUE TO THE SIZE OF THE GLENOSPHERE. 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 BECAUSE OF DISCOMFORT AND POLY WEAR OF THE HUMERAL CUP. **UPDATE: 5/1/2013 FURTHER INFORMATION INDICATES THAT THE DISCOMFORT WAS RELATED TO THE SIZE OF THE GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203745 DXTEND GLENOSPHERE ECC D38MM GLENSOPHERE KWS 3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST 5117495

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention