BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN RHK STEM

    MDR report key: 7054798 · Received November 22, 2017

    Report

    Report Number
    0001822565-2017-08080
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCT - UNKNOWN NEXGEN RHK FEMORAL, UNKNOWN NEXGEN RHK TIBIAL TRAY, UNKNOWN NEXGEN RHK BEARING, UNKNOWN NEXGEN RHK ASSEMBLY, AND UNKNOWN NEXGEN RHK PATELLA. REPORT SOURCE: LITERATURE: COTTINO, U., ABDEL, M. P., PERRY, K. I., MARA, K. C., LEWALLEN, D. G., & HANSSEN, A. D. (2017). LONG-TERM RESULTS AFTER TOTAL KNEE ARTHROPLASTY WITH CONTEMPORARY ROTATING-HINGE PROSTHESES. JBJS, 99(4), 324-330. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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: 0001822565-2017-07360, 0001822565-2017-07361, 0001822565-2017-07362, 0001822565-2017-08079, AND 0001822565-2017-08081. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE REPORTED ONE CASE OF DVT (DEEP VEIN THROMBOSIS) OCCURRED POST-OPERATIVELY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833812 UNKNOWN NEXGEN RHK STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R