BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICRO LATERAL FEMORAL 11MM

    MDR report key: 7491415 · Received May 7, 2018

    Report

    Report Number
    0001825034-2018-03078
    Event Type
    Injury
    Date Received
    May 7, 2018
    Date of Event
    February 23, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK062994
    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 UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO REMAINING IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: BIOMET TAPER ADAPTOR REMOVAL ASSEMBLY ITEM#: 110005232, LOT# 124300; BIOMET M2A-MAGNUM 52-60MM TPR INSRT-3 ITEM #: 139266 LOT #: 253770; BIOMET M2A-MAGNUM MOD HD SZ 52MM ITEM #: 157452 LOT #: 022620 ; BIOMET M2A-MAGNUM PF CUP 58ODX52ID ITEM#: US157858, LOT#: 172760. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02118, 0001825034 - 2018 - 03077.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY, THE TAPER ADAPTER AND STEM WOULD NOT DISENGAGE AND 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
    333964 TAPERLOC MICRO LATERAL FEMORAL 11MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 826730

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention