BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLASTY ANTERIOR STEM EXTRACTOR ADAPTE

    MDR report key: 7416684 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02409
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    November 30, 2017
    Report Date
    December 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE STEM CONFIRMED THE FRACTURED PORTION OF THE EXTRACTOR IS ENGAGED WITH THE THREADS OF THE STEM. THE STEM WAS MOSTLY FREE FROM DAMAGE AND A SMALL AMOUNT OF FOREIGN MATERIAL REMAINS AFFIXED TO THE POROUS COATING AND GOUGING WAS OBSERVED ON 2 SIDES OF THE NECK. VISUAL INSPECTION OF THE EXTRACTOR FOUND THE THREADED TIP FRACTURED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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). CONCOMITANT MEDICAL PRODUCTS: 51-107110, MICROPLASTY TPRLC 133 MP TYPE1 PPS HO 11.0, 6180904. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02408.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL RIGHT HIP PROCEDURE THE STEM WAS SEATED ABOVE THE DESIRED LEVEL WHICH HAD TO BE REMOVED. DURING THE STEM EXTRACTION, THE THREAD OF THE EXTRACTOR BROKE OFF INSIDE THE STEM. THE SURGEON HAD TO SCRAP THE STEM SINCE THE BROKEN EXTRACTOR WAS STILL IN THE THREADED HOLE. ANOTHER STEM OF THE SAME SIZE WAS USED TO COMPLETE THE SURGERY WITHOUT INCIDENT OR DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255394 MICROPLASTY ANTERIOR STEM EXTRACTOR ADAPTE SURGICAL, INSTRUMENT LXH ZIMMER BIOMET, INC. N/A ZB121201

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR