BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD (TM) CR FEMORAL INTERLOK

    MDR report key: 7762059 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-05110
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    March 7, 2016
    Report Date
    July 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS. CONCOMITANT MEDICAL PRODUCTS: BIOMET CC I-BEAM TRAY 79MM CATALOG # 141225 LOT # UNKNOWN, SERIES A PAT STD 34 3 PEG CATALOG # 184766 LOT # UNKNOWN, VANGUARD (TM) DCM CR TIBIAL BEARING CATALOG # 183460 LOT # UNKNOWN. THE REPORTED EVENT WAS NOT CONFIRMED AS NO PRODUCT WAS RECEIVED. 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 INFORMATION PROVIDED WAS LIMITED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034 - 2018 - 05099. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT MANIPULATION DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603989 VANGUARD (TM) CR FEMORAL INTERLOK KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention