BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 35.5MM

    MDR report key: 2911080 · Received January 4, 2013

    Report

    Report Number
    9616680-2013-90040
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE VIGILANCE RESPONSIBLE OF THE HOSPITAL, DR. (B)(6), REPORTED VIA FAX AN EVENT OF LOOSENING OF THE INVOLVED PRODUCTS: "A PATIENT OF (B)(6) UNDERWENT A SURGICAL PROCEDURE OF THR ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT EXPERIENCED A LUXATION, FOLLOWED BY THE DISASSEMBLY OF CEMENTED STEM. THE PATIENT UNDERWENT AN UNANTICIPATED REVISION SURGERY IN WHICH THE PRODUCTS INVOLVED WERE EXPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5252 EXETER V40 STEM 35.5MM IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA G3265894

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention