BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC-X ARCOMXL H/W 54/36MM 24

    MDR report key: 5765830 · Received July 1, 2016

    Report

    Report Number
    3002806535-2016-00522
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 3, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K023357.

    Description of Event or Problem · 1

    DURING BILATERAL TOTAL HIP ARTHROPLASTIES, THE LINER WAS UNSTABLE INSIDE OF THE ACETABULAR CUP AND THE ACETABULAR CUP FELT LOOSE IN THE ACETABULUM. THERE WAS A DELAY IN PROCEDURE OF APPROXIMATELY 10 MINUTES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420294 RINGLOC-X ARCOMXL H/W 54/36MM 24 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3680725

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR