BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 70

    MDR report key: 7239812 · Received February 3, 2018

    Report

    Report Number
    0001825034-2018-00662
    Event Type
    Injury
    Date Received
    February 3, 2018
    Date of Event
    September 28, 2017
    Report Date
    February 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT: POLISHED FINNED TIB TRAY 79MM CAT: 141255 LOT: 2013061634; SERIES A PAT STD 31 3 PEG CAT: 184764 LOT: 073910; VNGD CR TIB BRG 12X79/83 CAT: 183462 LOT: 930530. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE PROVIDED X-RAYS DETERMINED THE ALIGNMENT APPEARS NORMAL ON THE PROVIDED IMAGES AND THERE IS "POSSIBLE MILD LATERAL TILTING/SUBLUXATION OF THE PATELLA [AND] POSSIBLE MILD PERIPROSTHTIC LUCENCY ADJACENT TO THE LATERAL TIBIAL PLATE." REVIEW OF THE PROVIDED PHOTOS ONLY SHOWS THE EXPLANTED TIBIAL TRAY, FEMORAL, AND BEARING. BONEY INGROWTH CAN BE SEEN ON THE FEMORAL COMPONENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY FOUR YEAR POST IMPLANTATION DUE TO MALALIGNMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83200 VANGUARD CR ILOK FEM-LT 70 KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. 755620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R