BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNGD PS TIB BRG 12X71/75MM

    MDR report key: 7756466 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06281
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    June 21, 2011
    Report Date
    August 31, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VAN PS CLSD INTLK FEM-RT 65, CATALOG # 183208, LOT # UNKNOWN; BIOMET CC I-BEAM TRAY 75MM, CATALOG # 141224, LOT # UNKNOWN; BIOMET ARCOM 3 PEG/POST, CATALOG # UNKNOWN, LOT # UNKNOWN. OUR INVESTIGATION IS ONGOING. A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY TOTAL KNEE ARTHROPLASTY. IT WAS NOTED THROUGH RADIOGRAPHS OF THE RIGHT KNEE DEMONSTRATED POLYWEAR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600808 VNGD PS TIB BRG 12X71/75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR