BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X21X50 MODULAR HEAD WITH VARIABLE OFFSET

    MDR report key: 6107057 · Received November 16, 2016

    Report

    Report Number
    0001825034-2016-04705
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    June 3, 2015
    Report Date
    November 15, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 THE 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, "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. THE USE OF A GLENOID PROSTHESIS IN PATIENTS WITH A DEFICIENT ROTATOR CUFF COULD INCREASE THE RISK OF GLENOID COMPONENT LOOSENING DUE TO NON-ANATOMIC LOADING CONDITIONS." CONCOMITANT MEDICAL PRODUCT - MD HYBRID GLENOID BASE 4MM, CATALOG#: 113954 LOT#: 176780; BIOMET GLENOID POST, CATALOG#: PT-113950 LOT#: 921020; BIOMET STANDARD TAPER, CATALOG#: 118001 LOT#: 739200; BIOMET STEM, CATALOG#: 113631 LOT#: 124980.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO A ROTATOR CUFF TEAR. THE GLENOID AND HUMERAL HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758699 VERSA-DIAL 46X21X50 MODULAR HEAD WITH VARIABLE OFFSET PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 488790

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R