BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEXGEN RHK STEM

    MDR report key: 7054606 · Received November 22, 2017

    Report

    Report Number
    0001822565-2017-08059
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    February 15, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NEXGEN PATELLA; UNKNOWN NEXGEN RH TIBIAL TRAY; UNKNOWN NEXGEN RH FEMUR; UNKNOWN NEXGEN RHK BEARING; UNKNOWN NEXGEN RHK ASSEMBLY. 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: 0001822565-2017-08060, 0001822565 - 2017 - 07354 AND 0001822565 - 2017 - 07353.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT RADIOGRAPHY INDICATED LOOSENING IN THIRTEEN PATIENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENTS IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834103 UNKNOWN NEXGEN RHK STEM PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1