BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD CR

    MDR report key: 6949789 · Received October 13, 2017

    Report

    Report Number
    0001825034-2017-08697
    Event Type
    Injury
    Date Received
    October 13, 2017
    Report Date
    October 13, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. 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 AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION: UNDER POSSIBLE ADVERSE EFFECTS: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4: 4 LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY. HOWELL, S. M., PAPADOPOULOS, S., KUZNIK, K., GHALY, L. R., & HULL, M. L. (2015). DOES VARUS ALIGNMENT ADVERSELY AFFECT IMPLANT SURVIVAL AND FUNCTION SIX YEARS AFTER KINEMATICALLY ALIGNED TOTAL KNEE ARTHROPLASTY? SPRINGER. DOI:10.1007/S00264-015-2743-5. 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. ZIMMER BIOMET COMPLAINT NUMBER: CMP-0300380 THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "DOES VARUS ALIGNMENT ADVERSELY AFFECT IMPLANT SURVIVAL AND FUNCTION SIX YEARS AFTER KINEMATICALLY ALIGNED TOTAL KNEE ARTHROPLASTY?"ONE PATIENT WAS IDENTIFIED IN THE ARTICLE THAT UNDERWENT REVISION DUE TO PATELLA INSTABILITY ON AN UNKNOWN DATE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728247 UNKNOWN VANGUARD CR JWH ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R