BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS+ TIB BRG 10X63/67MM

    MDR report key: 6543466 · Received May 4, 2017

    Report

    Report Number
    0001825034-2017-02974
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    July 15, 2015
    Report Date
    November 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS CMP-(B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-01253, 0001825034-2017-02971, 0001825034-2017-02974 & 0001825034-2017-02976.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-02971; 0001825034-2017-02971-1; 0001825034-2017-02971-2; 0001825034-2017-01253; 0001825034-2017-01253-1; 0001825034-2017-01253-2; 0001825034-2017-01253-3; 0001825034-2017-02976; 0001825034-2017-02976-1; 0001825034-2017-02976-2; 0001825034-2017-02974; 0001825034-2017-02974-1; 0001825034-2017-02974-2. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: P/N 183132 VAN PS OPEN INTL FEM-LT 70 L/N 049170; P/N 141232 BIOMET COCR FINNED TIB TRAY 67 MM L/N J3477544; P/N 183720 VNGD PS+ TIB BRG 10X63/67MM L/N 665080; P/N 184764 SERIES A PAT STD 31 3 PEG L/N 014690. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 PATIENTS LEFT KNEE HAS BEEN INDICATED FOR REVISION DUE TO INSTABILITY ON AN UNKNOWN DATE. THE PATIENT HAD FLUID REMOVED FROM KNEE AND IT WAS CHECKED FOR INFECTION AND WAS NEGATIVE. NO REVISION HAS OCCURRED YET. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE HAS BEEN INDICATED FOR REVISION TWO YEARS POST-IMPLANTATION DUE TO PAIN AND STIFFNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGED TO PAIN AND STIFFNESS TWO YEARS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326945 VNGD PS+ TIB BRG 10X63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 665080

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other