BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA PSL CUP/CLUSTR SHELL 54MM

    MDR report key: 3291420 · Received August 16, 2013

    Report

    Report Number
    0002249697-2013-02752
    Event Type
    Injury
    Date Received
    August 16, 2013
    Date of Event
    June 1, 2013
    Report Date
    July 31, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K942900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CORROSION INVOLVING A SECURFIT SHELL WAS REPORTED. BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION OF THE SECURFIT SHELL AS IT WAS USED WITH ANOTHER MANUFACTURER'S FEMORAL STEM AND HEAD. A REVIEW OF THE IFU CURRENTLY INCLUDED WITH THE DEVICE AT THE TIME OF MANUFACTURE, QIN 4302, STATES THE FOLLOWING WARNINGS: HOWMEDICA OSTEONICS CORP. STRONGLY ADVISES AGAINST THE USE OF ANOTHER MANUFACTURER¿S FEMORAL STEM COMPONENT WITH ANY HOWMEDICA OSTEONICS ACETABULAR SYSTEM COMPONENT. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP. FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT.

    Description of Event or Problem · 1

    (B)(4) REPORT RECEIVED WITH FOLLOWING DESCRIPTION : "CHRONIC PAIN IN RELATION TO A MAJOR OSTEOLYSIS IN THE HIP. METALLOSIS PROBLEM " IT CONCERNS A PROTHEOS IMPLANT (STEM AND HEAD) WITH A STRYKER SECURIFIT CUP.

    Description of Event or Problem · 1

    (B)(6) REPORT RECEIVED WITH FOLLOWING DESCRIPTION : "CHRONIC PAIN IN RELATION TO A MAJOR OSTEOLYSIS IN THE HIP. METALLOSIS PROBLEM." IT CONCERNS A PROTHEOS IMPLANT (STEM AND HEAD) WITH A STRYKER SECURIFIT CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396873 SECUR-FIT HA PSL CUP/CLUSTR SHELL 54MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention