BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM, TIBIAL TRAY

    MDR report key: 7292117 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-01362
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    September 20, 2016
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK132873
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01361, 0001825034 - 2018 - 01368, 0001825034 - 2018 - 01370. CONCOMITANT: 195919 VGXP INTLK FEMORAL LT 57.5 LOT 050320; 195809 VGXP XP E1 TIB BRG LL 11X63 LOT 811970; 195879 VGXP XP E1 TIB BRG LM 11X63 LOT 811110. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE STUDY THE PATIENT HAD MODERATE AND SEVERE PAIN, AMBULATION DIFFICULTIES, TROUBLE PERFORMING NORMAL ACTIVITIES, LOSS OF RANGE OF MOTION, LIMPING, FEELINGS OF KNEE INSTABILITY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136417 VANGUARD COMPLETE KNEE SYSTEM, TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 639630

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other