BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN POR FEMORAL LEFT 67.5

    MDR report key: 8743862 · Received June 28, 2019

    Report

    Report Number
    0001825034-2019-02708
    Event Type
    Injury
    Date Received
    June 28, 2019
    Report Date
    July 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCTS REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UDI # (B)(4). TIBIAL TRAY ITEM # 141274 LOT # 127910. FINNED STEM ITEM # 141314 LOT # 479370. PATELLA ITEM # 141357 LOT # 778860. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02709, 0001825034-2019-02710, 0001825034-2019-02711.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY APPROXIMATELY 3.5 YEARS AGO; SUBSEQUENTLY THE PATIENT IS BEING REVISED FOR UNKNOWN REASON AT A FUTURE DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538627 VANGUARD PS OPEN POR FEMORAL LEFT 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 596630

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention