BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN RHK ASSEMBLY

    MDR report key: 7053917 · Received November 22, 2017

    Report

    Report Number
    0001822565-2017-08035
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    February 15, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN NEXGEN RHK BEARING, UNKNOWN NEXGEN RHK FEMORAL, UNKNOWN NEXGEN RHK TIBIAL TRAY, UNKNOWN NEXGEN RHK PATELLA, UNKNOWN NEXGEN RHK STEM. INITIAL REPORTER: 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. 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: 0001822565-2017-07363, 0001822565-2017-07364, 0001822565-2017-07365, 0001822565-2017-08034, 0001822565-2017-08036.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE THAT ONE CASE OF PERONEAL NERVE PALSY OCCURRED POST-OPERATIVELY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832731 UNKNOWN NEXGEN RHK ASSEMBLY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other