BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN KNEE FEMORAL

    MDR report key: 6964823 · Received October 20, 2017

    Report

    Report Number
    0001822565-2017-07260
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    February 4, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). LITERATURE: YOUNG-HOO KIM, JANG-WON PARK, JUN-SHIK KIM ¿DO HIGH-FLEXION TOTAL KNEE DESIGNS INCREASE THE RISK OF FEMORAL COMPONENT LOOSENING?¿ THE JOURNAL OF ARTHROPLASTY 32 (2017) 1862-1868. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO KNEES IN THE STANDARD KNEE GROUP WERE REVISED OF FEMORAL COMPONENT AT TEN YEARS AFTER SURGERY OF ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745379 UNKNOWN NEXGEN KNEE FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10