BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 36MM/+5

    MDR report key: 3450513 · Received November 5, 2013

    Report

    Report Number
    0002249697-2013-03556
    Event Type
    Injury
    Date Received
    November 5, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K910988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PATIENT THE CONVERSION FROM BIPOLAR TO TOTAL HIP DUE TO ARTHRITIS WAS REPORTED. IT WAS ALSO REPORTED THAT FEMORAL HEAD WAS REPLACED. IN ADDITION, IT WAS REPORTED THAT THE ACETABULAR SHELL CUP AND ACETABULAR LINER WERE EITHER MANUFACTURED BY ZIMMER OR SMITH & NEPHEW. CONCLUSION: STRYKER¿S IFUS INDICATES ¿HOWMEDICA OSTEONICS CORP. STRONGLY ADVISES AGAINST THE USE OF ANOTHER MANUFACTURER¿S TAPERED FEMORAL STEM OR ACETABULAR COMPONENT WITH ANY HOWMEDICA OSTEONICS FEMORAL BEARING HEAD COMPONENT. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP. FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT.¿ BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION.

    Description of Event or Problem · 1

    PATIENT WAS CONVERTED FROM BIPOLAR TO TOTAL HIP. EXPLANTED BIPOLAR HEAD AND REPLACED WITH LFIT 36 HEAD. SURGERY WAS SUCCESSFUL.

    Description of Event or Problem · 1

    UPDATE: AS PER REP. INDICATED THEY COULDN'T FIND ANYTHING ON THE BIPOLAR HEAD BUT WERE ABLE TO FIND THE CAT # FOR THE STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568455 C-TAPER COCR LFIT HEAD 36MM/+5 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention