BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN RHK PATELLA

    MDR report key: 7064049 · Received November 28, 2017

    Report

    Report Number
    0001822565-2017-08087
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    February 15, 2017
    Report Date
    November 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NEXGEN RHK BEARING, CATALOG #: UNKNOWN LOT #: UNKNOWN; UNKNOWN NEXGEN RHK FEMORAL, CATALOG #: UNKNOWN LOT #: UNKNOWN; UNKNOWN NEXGEN RHK TIBIAL TRAY, CATALOG #: UNKNOWN LOT #: UNKNOWN; UNKNOWN NEXGEN RHK ASSEMBLY, CATALOG #: UNKNOWN LOT #: UNKNOWN; UNKNOWN NEXGEN RHK STEM, CATALOG #: UNKNOWN LOT #: UNKNOWN. (B)(6). 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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-07322, 0001822565-2017-07321, 0001822565-2017-07323, 0001822565-2017-08085, 0001822565-2017-08086, 0001822565-2017-08087. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    THE STUDY REPORTED TEN CASES OF MECHANICAL FAILURE REQUIRING REVISION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842523 UNKNOWN NEXGEN RHK PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R