BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS MODULAR REVISION HIP

    MDR report key: 6337731 · Received February 16, 2017

    Report

    Report Number
    0001825034-2017-00655
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    January 19, 2017
    Report Date
    April 16, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K090757.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIAL BODY WOULD NOT DETACH FROM THE DISTAL STEM. THE SURGEON WAS UNABLE TO REMOVE THE SCREW FROM THE BODY, CAUSING DAMAGE TO THE SCREWDRIVER. A SMALLER DISTAL COMPONENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117758 ARCOS MODULAR REVISION HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 361150

    Patients

    Seq Age Sex Outcome Treatment
    1