BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK360DA360 KNEE SYSTEM FEMORAL LEFT-WITH SCREW 65MM

    MDR report key: 6051723 · Received October 24, 2016

    Report

    Report Number
    0001825034-2016-04249
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    September 29, 2016
    Report Date
    April 6, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE RETURNED TO MANUFACTURER 18-NOV-2016. MEDICAL DEVICES: BIOMET DISTAL FEMORAL AUGMENT CATALOG # 185324,LOT # 205760, BIOMET SPLINED KNEE SYSTEM 12 MM X 80 MM, CATALOG # 141612, LOT # 303080, BIOMET VANGAURD SSK 360 TIBIAL TRAY 63 MM, CATALOG # 185201,LOT # 264980, BIOMET VANGAURD SSK 360 OFFSET ADAPTOR 5 MM CATALOG # 185211, LOT # 633340, BIOMET VANGAURD SSK 360 TIBIAL AUGMENT 63 MM X 15 MM CATALOG # 185241, LOT # 894790, BIOMET VANGAURD SSK 360 TIBIAL CRUCIATE WING SMALL, CATALOG # 185650, LOT # 687730, BIOMET DISTAL FEMORAL AUGMENT 5 MM X 65 MM CATALOG # 185304, LOT # 205540, BIOMET VANGAURD SSK 360 DISTAL FEMUR AUGMENT 10 MM X 65 MM CATALOG # 185384, LOT # 020260, BIOMET VANGAURD SSK 360 OFFSET ADAPTOR 5 MM CATALOG # 185211, LOT # 019390, BIOMET VANGAURD SSK 360 POSTERIOR AUGMENT 5 MM X 65 MM CATALOG # 185344, LOT # 648110, BIOMET VANGAURD SSK 360 DISTAL FEMORAL AUGMENT 10 MM X 65 MM CATALOG # 185404, LOT # 305900, BIOMET NON-CONSTRAINED VANGUARD DCM TIBIAL BEARING ARCOM UHMWPE 18 MM X 63/67 MM, CATALOG # 185068, LOT # 924340. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE FEMORAL SCREW SHOWS DENTS AND SCRATCHES ON THE HEAD AND FLATTENING ON MULTIPLE PARTS OF THE THREADS. THE SCREW COMPLETELY DISASSEMBLED FROM THE FEMORAL COMPONENT IN THE OPERATING THEATRE. THE COMPLAINT IS THEREFORE CONFIRMED. DIMENSIONAL ANALYSIS OF THE PRODUCT IS IMPOSSIBLE DUE TO THE EXISTING DAMAGE FROM BEING IMPLANTED FOR OVER THREE YEARS. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTOR WITH NO DEVIATIONS OR ABNORMALITIES. REVIEW OF COMPLAINT HISTORY FOUND ONE ADDITIONAL COMPLAINT FOR THIS ISSUE, HOWEVER NO FURTHER ACTION NECESSARY DUE TO THE INFREQUENCY OF EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    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 POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY."

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO THE FEMORAL SCREW BACKING OUT. THE LOOSE SCREW AND THE TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702218 VANGUARD SSK360DA360 KNEE SYSTEM FEMORAL LEFT-WITH SCREW 65MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 2771936

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R