BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM TIBIAL BEARING ANTERIOR STABILIZED 14MM X 75MM

    MDR report key: 6117123 · Received November 21, 2016

    Report

    Report Number
    0001825034-2016-04774
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    November 3, 2016
    Report Date
    February 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK050222
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 IT STATES THAT "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."

    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 - VANGAURD RIGHT FEMORAL CATALOG 183050 LOT 655520; BIOMET REGENEREX TIBIAL TRAY CATALOG 141274 LOT 657770; BIOMET FINNED STEM CATALOG 141314 LOT 695850. VISUAL INSPECTION OF THE BEARING SHOWS DAMAGE ON THE LEFT CONDYLE POSTERIORLY. THE DAMAGE DOES NOT APPEAR TO BE ABRASION, BUT PERHAPS PLASTIC DEFORMATION. THE MEDIAL SIDE OF THE CONDYLE HAS SOME MATERIAL EXTRUDED AND IS PROTRUDING OVER THE LIP OF THE BEARING. PER THE COMPLAINT, THE JOINT WAS UNSTABLE, SO IT IS POSSIBLE THE FEMORAL COMPONENT AND BEARING WERE NOT PROPERLY ARTICULATING WITH EACH OTHER. IF THE TIBIA PROTRUDED ANTERIORLY RELATIVE TO THE FEMUR, THE FEMORAL COMPONENT WOULD BE EXERTING PRESSURE ON THE POSTERIOR EDGE OF THE BEARING, CAUSING DEFORMATION SIMILAR TO WHAT IS SEEN IN THE PICTURE. -THIS DEVICE IS USED FOR TREATMENT. -THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED:183050, 189084, AND 141274. -ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SIX YEARS POST IMPLANTATION DUE TO INSTABILITY. THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768650 VANGUARD DCM TIBIAL BEARING ANTERIOR STABILIZED 14MM X 75MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 359750

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R