BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPER ADAPTOR REMOVAL ASSEMBLY

    MDR report key: 7369349 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02118
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    February 23, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RETURNED INSTRUMENT. VISUAL INSPECTION CONFIRMED THAT THE REMOVAL SHAFT HAD FRACTURED. NO OTHER SIGNIFICANT DAMAGE WAS OBSERVED ON THE THREADS OF THE SHAFT. IMPACT MARKS AND SCRATCHING WERE FOUND ON THE KNURLED PORTION OF THE HANDLE AND WRENCH. NO DAMAGE WAS OBSERVED TO THE REMOVAL BODY OR ITS THREADS. HARDNESS TESTING SHOWED THE HARDNESS TO BE WITHIN SPECIFICATION. THE PRODUCT WAS DETERMINED TO BE CONFORMING. THE DEVICE HAS A POTENTIAL FIELD AGE OF OVER 5 YEARS, IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS USED IN THE FIELD. DEVICE HISTORY RECORDS (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    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. CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A-MAGNUM MOD HD SZ 52MM ITEM #: 157452 LOT #: 022620, BIOMET M2A-MAGNUM 52-60MM TPR INSRT-3 ITEM #: 139266 LOT #: 253770.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY, THE TAPER ADAPTER REMOVAL TOOL BROKE, RESULTING IN A SURGICAL DELAY GREATER THAN 30 MINUTES. THE TAPER WAS UNABLE TO BE REMOVED WITHOUT THE TOOL, SO THE PATIENT WAS UNABLE TO BE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212879 TAPER ADAPTOR REMOVAL ASSEMBLY PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 124300

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention