BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSFIRE ECCENTRIC INSERT 10

    MDR report key: 3120441 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01706
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K974685
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND 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, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE MANUFACTURE DATE. 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. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DR (B)(6) WAS DOING A SECOND REVISION ON A SERIES II LINER FOR PAIN AND IN THE X-RAY IT LOOKED TO HAVE A BROKEN LOCKING MECHANISM.

    Description of Event or Problem · 1

    DR. (B)(6) WAS DOING A SECOND REVISION ON A SERIES II LINER FOR PAIN AND IN THE X-RAY, IT LOOKED TO HAVE A BROKEN LOCKING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222474 CROSSFIRE ECCENTRIC INSERT 10 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 1WHHT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention