BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCIN HIP SYSTEM

    MDR report key: 1421053 · Received July 24, 2009

    Report

    Report Number
    3006059396-2009-00002
    Event Type
    Injury
    Date Received
    July 24, 2009
    Report Date
    July 22, 2009
    Manufacturer
    CARDO MEDICAL
    Product Code
    JDI
    PMA / PMN Number
    K073068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF PT X-RAYS WERE USED TO EVALUATE THAT THE IMPLANT WAS THE CORRECT SIZE AS LABELED. IN ADDITION, BROACH INSTRUMENTS USED DURING THE SURGERY WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO ISSUES WERE IDENTIFIED DURING THE REVIEW. USAGE OF PRODUCTS FROM THE SAME LOT WERE REVIEWED AND PREVIOUSLY 6 OF THE STEMS FROM THE SAME LOT HAD BEEN IMPLANTED WITH NO ISSUES. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE COMPLAINT IS CONSIDERED CLOSED. IF FURTHER INFO IS RECEIVED THE COMPLAINT WILL BE RE-OPENED. ADDITIONAL SUSPECT MEDICAL DEVICE: MODEL # 704-1500; CATALOG # 704-1500; LOT # 19983-081908.

    Description of Event or Problem · 1

    PT WAS HAVING A BILATERAL TOTAL HIP REPLACEMENT. DURING INSERTION OF THE STEMS THE PT'S DISTAL FEMURS FRACTURED. THE FRACTURES WERE REPAIRED USING CABLES AS IS STANDARD PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCIN HIP SYSTEM TOTAL HIP SYSTEM JDI CARDO MEDICAL 705-1500 19973-081208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention