BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS-K DIAPHYSEAL SEGMENT 7 CM W/SCREWS

    MDR report key: 5810559 · Received July 20, 2016

    Report

    Report Number
    0001825034-2016-02674
    Event Type
    Injury
    Date Received
    July 20, 2016
    Report Date
    June 21, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK020970
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: OSS FEMORAL BUSHING, CATALOG#: 161034, LOT#: 153220. OSS TIBIAL BEARING, CATALOG#: 150410, LOT#: 464070. OSS FEMORAL MODULAR SEGMENT, CATALOG#: 161012, LOT#: 872880. OSS YOKE, CATALOG#: 133080, LOT#: 133080. OSS AXLE, CATALOG#: 161035, LOT#: 228210. OSS LOCKING PIN, CATALOG#: 150478, LOT#: 158660. OSS STACKING ADAPTER, CATALOG#: 150483, LOT#: 192940. OSS STACKING ADAPTER, CATALOG#: 150483, LOT#: 689000.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR REVISION DUE TO A TAPER FRACTURE APPROXIMATELY 7 YEARS POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462764 OSS-K DIAPHYSEAL SEGMENT 7 CM W/SCREWS PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 965880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention