BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 10DEG LINER RINGLOC-X 58MM

    MDR report key: 6560274 · Received May 11, 2017

    Report

    Report Number
    3002806535-2017-00314
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    February 24, 2017
    Report Date
    February 14, 2018
    Manufacturer
    .
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. NO OTHER COMPLAINTS FROM THIS ITEM/LOT HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS IMPLANTED WITH AN EXPIRED POLY LINER DURING A HIP ARTHROPLASTY. NO PATIENT CONSEQUENCES OR INTERVENTION HAVE BEEN REPORTED. THE IMPLANT WAS APPROXIMATELY SIX MONTHS PAST THE STERILE EXPIRATION DATE AT TIME OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343165 E1 10DEG LINER RINGLOC-X 58MM PROSTHESIS, HIP LPH . N/A 2476316

    Patients

    Seq Age Sex Outcome Treatment
    1