BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK 360 R FEM 70MM

    MDR report key: 5851608 · Received August 5, 2016

    Report

    Report Number
    0001825034-2016-02956
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    June 30, 2016
    Report Date
    November 21, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." (B)(6). REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: BMT SMOOTH KNEE STEM 16X80 ITEM: 145026, LOT: 045450, THERAPY DATE: (B)(6) 2016. VG DA 360 O/S TIB TRAY COCR 79 ITEM: 161432, LOT: 2857200, THERAPY DATE: (B)(6) 2016. BMT SMOOTH KNEE STEM 12X80 ITEM: 145022, LOT: 470020, THERAPY DATE: (B)(6) 2016. VG DA 360 O/S TIB TRAY COCR 79 ITEM: 161432, LOT: 2857200, THERAPY DATE: (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    DURING A LEFT KNEE REVISION PROCEDURE, A RIGHT SIDE FEMORAL COMPONENT WAS IMPLANTED BY THE SURGEON. THERE ARE NO PLANS TO REVISE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502172 VNGD SSK 360 R FEM 70MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 3702874

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other