BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4221332 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04092
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING ASSEMBLY ISSUE INVOLVING AN UNKNOWN TIBIAL NAIL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. -DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. -COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN WICHITA TIBIAL NAIL. THE SALES REP CONFIRMED THAT THE PATIENT'S PAST SURGERIES DID NOT INVOLVE STRYKER DEVICES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD SEVERAL SURGERIES DUE TO TOTAL KNEE FAILED AND BONE LOSS. SALES REP REPORTED PATIENT WAS SO LARGE THEY WERE NOT ABLE TO CONNECT THE FEMORAL NAIL AND TIBIAL NAIL TOGETHER. DOCTOR THEN CLOSED PATIENT WITH ALL HARDWARE IMPLANTED, BUT NOT ATTACHED AND TRANSFERRED TO A DIFFERENT INSTITUTION THAT WAS MORE CAPABLE OF HANDLING THE SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD SEVERAL SURGERIES DUE TO TOTAL KNEE FAILED AND BONE LOSS. SALES REP REPORTED PATIENT WAS SO LARGE THEY WERE NOT ABLE TO CONNECT THE FEMORAL NAIL AND TIBIAL NAIL TOGETHER. DOCTOR THEN CLOSED PATIENT WITH ALL HARDWARE IMPLANTED BUT NOT ATTACHED AND TRANSFERRED TO A DIFFERENT INSTITUTION THAT WAS MORE CAPABLE OF HANDLING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701842 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other