BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DXTEND SZ 42 GLENOSPHERE (NOT REMOVED)

    MDR report key: 2621359 · Received June 19, 2012

    Report

    Report Number
    1818910-2012-14502
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A DEPUY (B)(4) SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS FOR THE CUP AND FOUND THE PRODUCT CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE CUP PART AND LOT NUMBER COMBINATION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED FOR THE GLENOSPHERE WAS UNAVAILABLE. PROVIDED INFORMATION STATES A +6 INSERT WAS REMOVED AND A +9 INSERT WAS IMPLANTED. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. 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 DISLOCATION. (RIGHT SHOULDER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY DXTEND SZ 42 GLENOSPHERE (NOT REMOVED) GLENOID PROSTHESIS KWR DEPUY FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention