BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO BI-METRIC HIP SYSTEM STANDARD FEMORAL STEM

    MDR report key: 7648100 · Received June 28, 2018

    Report

    Report Number
    0001825034-2018-04332
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 1, 2018
    Report Date
    February 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK070274
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION PERFORMED TO VERIFY ITEM (192414) AND LOT (944680) NUMBER. VISUAL INSPECTION OF THE BOX LABEL, UNUSED LABELS INSIDE THE BOX AND THE LABEL AFFIXED ON THE CAVITY LID ALL HAVE THE SAME ITEM AND LOT NUMBER LISTED. VISUAL INSPECTION OF THE PACKAGED PART SHOWS THE ETCHED LOT NUMBER TO BE 621550. THIS CONFIRMS THE PACKAGED PART IS NOT CONFORMING TO THE BOX THAT IT WAS PACKAGED IN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE DETERMINED AS A MANUFACTURING DEFICIENCY. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCORRECT ITEM WAS RECEIVED IN PACKAGE. THE SURGERY WAS COMPLETED WITH A SECOND DEVICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489928 ECHO BI-METRIC HIP SYSTEM STANDARD FEMORAL STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 944680

    Patients

    Seq Age Sex Outcome Treatment
    1