BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 H/W 60/36MM 26

    MDR report key: 5809992 · Received July 20, 2016

    Report

    Report Number
    3002806535-2016-00563
    Event Type
    Injury
    Date Received
    July 20, 2016
    Date of Event
    July 8, 2013
    Report Date
    June 21, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE NECESSARY MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. 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. THIS REPORT IS NUMBER 2 OF 4 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00562 / 00563 & 1825034-2016-02658 / 02659). PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT A RIGHT CLOSED REDUCTION PROCEDURE APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO LUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464382 RINGLOC-X E1 H/W 60/36MM 26 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 2841624

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention