BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORSE TAPER COCR HEAD MM

    MDR report key: 3447924 · Received November 4, 2013

    Report

    Report Number
    0002249697-2013-03552
    Event Type
    Injury
    Date Received
    November 4, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. A REVIEW OF THE PACKAGING INSERT, Q4309 REV E, INDICATED THE FOLLOWING: 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. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 1

    HEAD CHANGE DUE TO POLY WEAR IN AN S-ROM CUP. CHANGED LINER AND HEAD.

    Description of Event or Problem · 1

    HEAD CHANGE DUE TO POLY WEAR IN AN S-ROM CUP. CHANGED LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565882 MORSE TAPER COCR HEAD MM IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH HA139A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention