BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA ACE/LOW PROFILE SHELL 46MM

    MDR report key: 2831082 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02198
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS MAHWAH
    Product Code
    KWB
    PMA / PMN Number
    K852135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION(INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT LATER TIME, 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 THAT: "A PT UNDERWENT A SURGICAL PROCEDURE OF THE HIP DUE TO COXARTHRITIS ON 1991. THE PT UNDERWENT AN UNANTICIPATED REVISION SURGERY WITH THE REPLACEMENT OF ALL THE COMPONENTS OF THE IMPLANT DUE TO ASEPTIC LOOSENING OF THE IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA ACE/LOW PROFILE SHELL 46MM IMPLANT KWB STRYKER ORHTOPAEDICS MAHWAH NA RHWKA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention