BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 2875027 · Received December 17, 2012

    Report

    Report Number
    1818910-2012-83799
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    January 26, 2012
    Report Date
    December 11, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    DHR ANALYSIS: PRODUCT CODE (B)(4): PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. PRODUCT CODE (B)(4): PRODUCTS WERE CONFORM AND MET SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR FAILURE INVESTIGATION REPORT. NO FURTHER ANALYSIS WAS POSSIBLE BECAUSE THE PRODUCT WERE NOT RETURNED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT UNDERGO AN EXPLANT OF FEMORAL PROSTHESIS CAUSED BY STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 11 DEPUY HIP IMPLANT KWA DEPUY INTERNATIONAL 2806928

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention