BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 10DEG 54/32MM 24

    MDR report key: 6991220 · Received October 31, 2017

    Report

    Report Number
    3002806535-2017-00995
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    September 20, 2017
    Report Date
    March 2, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. FOLLOW UP CONFIRMED THAT THE DEVICE WAS SHIPPED PRIOR TO THE EXPIRATION DATE. THE PRODUCT HAD NOT BEEN REMOVED FROM CONSIGNMENT KIT ONCE IT PASSED THE EXPIRATION DATE AND IT WAS ERRANTLY TAKEN INTO A PROCEDURE. NO PRODUCT HAS BEEN RETURNED AS ITEM IS STILL IMPLANTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. CAUSE OF EVENT WAS USER ERROR. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4) REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). 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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K023357. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A DEVICE PAST ITS STERILE EXPIRATION DATE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771030 RINGLOC-X E1 10DEG 54/32MM 24 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2712289

    Patients

    Seq Age Sex Outcome Treatment
    1 Other