BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC-X ARCOMXL H/W 50/32MM 23

    MDR report key: 5645723 · Received May 10, 2016

    Report

    Report Number
    3002806535-2016-00239
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 14, 2016
    Report Date
    April 15, 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. 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. 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. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE ENGLISH AND CHINESE LABELS DO NOT MATCH THE ETCHED IMPLANT LOT NUMBER. THERE WAS NO PATIENT INJURY AND NO DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298551 RINGLOC-X ARCOMXL H/W 50/32MM 23 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3671499

    Patients

    Seq Age Sex Outcome Treatment
    1