BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 H/+3MM 50/36MM 23

    MDR report key: 5401302 · Received February 1, 2016

    Report

    Report Number
    3002806535-2016-00047
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    December 24, 2015
    Report Date
    January 13, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2015 DUE TO UNKNOWN REASONS. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2015 DUE TO DISLOCATION. THE FEMORAL HEAD AND POLYETHYLENE ACETABULAR LINER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60447 RINGLOC-X E1 H/+3MM 50/36MM 23 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3598797

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R