BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSTRAINED VANGUARD DCM TIBIAL BEARING 12MM X 63/67MM

    MDR report key: 6031525 · Received October 14, 2016

    Report

    Report Number
    0001825034-2016-04131
    Event Type
    Death
    Date Received
    October 14, 2016
    Date of Event
    September 22, 2016
    Report Date
    February 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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). CONCOMITANT PRODUCT: VANGUARD SSK 360 RIGHT FEMORAL 65MM CATALOG 185264 LOT 3595107; VANGUARD 360 DISTAL FEMORAL AUGMENT 65X10MM RL/LM CATALOG 185384 LOT 841320; VANGUARD 360 DISTAL FEMORAL AUGMENT 65X5MM LL/RM CATALOG 185324 LOT 915130; VANGUARD 360 UNIVERSAL POSTERIOR FEMORAL AUGMENT 65X10MM CATALOG 185424 LOT 524140; BIOMET SPLINED KNEE STEM V2 17X80MM CATALOG 148307 LOT 264630; BIOMET 360 TIBIAL 5MM OFFSET ADAPTER CATALOG 185211 LOT 082360; BIOMET 360 TIBIAL TRAY 67MM CATALOG 185202 LOT 606490; BIOMET SPLINED KNEE STEM V2 17X40MM CATALOG 148292 LOT 818750; BIOMET 360 TIBIAL 5MM OFFSET ADAPTER CATALOG 185211 LOT 045340; VANGUARD 360 SMALL TIBIAL SLEEVE CATALOG 185531 LOT 335530; VANGUARD 360 TIBIAL SLEEVE CATALOG 185538 LOT 107470. THIS DEVICE IS USED FOR TREATMENT. THE COMPLAINT COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. NO MEDICAL RECORDS RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE.

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04130 / 04131).

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY REPORTEDLY EXPIRED DUE TO UNKNOWN CAUSES APPROXIMATELY SIX MONTHS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681260 CONSTRAINED VANGUARD DCM TIBIAL BEARING 12MM X 63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 517520

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death