BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIBIAL BEARING

    MDR report key: 8042385 · Received November 6, 2018

    Report

    Report Number
    0001825034-2018-10179
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    August 2, 2010
    Report Date
    November 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR FEMORAL COMPONENT CAT#: 183022, LOT#: UNK, BIOMET CC I-BEAM TRAY CAT#:141221, LOT#:UNK, UNKNOWN KNEE PATELLA CAT#:UNK, LOT#:UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN.  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 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF POLY, SIX YEARS AFTER PRIMARY LEFT TOTAL KNEE ARTHROPLASTY DUE TO FLEXION INSTABILITY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884049 VANGUARD CR TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R