BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X24X47 HUM HEAD

    MDR report key: 3075875 · Received April 24, 2013

    Report

    Report Number
    0001825034-2013-00404
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 VARIOUS WARNINGS AND PRECAUTIONS IN THE PACKAGE INSERT INCLUDING: "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." AND "MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." AND - THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE IMPLANTS AND INSTRUMENTS, PRIOR TO PERFORMING SURGERY." UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00401-1 / 00403-1 & 00404).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2013 DUE TO STEM SITTING PROUD AND IMPROPER PLACEMENT OF REMAINING IMPLANTS. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE NOTES INDICATE SUBLUXATION AND DISLOCATION OF RIGHT GLENOHUMERAL JOINT AND AN ANTEVERTED GLENOID COMPONENT. OPERATIVE NOTES CONFIRM THE STEM, HEAD AND GLENOID WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177765 VERSA-DIAL 46X24X47 HUM HEAD PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 171400

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R