BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 10DEG 54/36MM

    MDR report key: 3030371 · Received April 2, 2013

    Report

    Report Number
    3002806535-2013-00054
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY HIP SURGERY ON (B)(6), 2013. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2013 DUE TO LUXATION. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134641 RINGLOC-X E1 10DEG 54/36MM VITAMIN E 10 DEG. RINGLOC-X LINER JDI BIOMET UK LTD. N/A 2726365

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R