BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SEGMENTAL REVISION SYSTEM - 12MM X 75 MM MODULAR STEM

    MDR report key: 6224013 · Received January 4, 2017

    Report

    Report Number
    0001825034-2017-00034
    Event Type
    Injury
    Date Received
    January 4, 2017
    Report Date
    December 9, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 12 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." CONCOMITANT MEDICAL PRODUCT: CKST PROX BDY SET W HD, CATALOG#: CP561978, LOT#: 905300; COMPR SRS IC SEG - 60MM, CATALOG#: 211225, LOT #: 346840; CKST SHELL W/STRAP SCREW LNR, CATALOG#: CP561977 LOT#: 905220. THERAPY DATE: (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR HUMERAL REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO A DISTAL FRACTURE OF THE STEM. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5820 COMPREHENSIVE SEGMENTAL REVISION SYSTEM - 12MM X 75 MM MODULAR STEM PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS N/A 563850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R