BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SEGMENTAL REVISION SYSTEM STEM TO TRIAL ADAPTER

    MDR report key: 2920131 · Received January 17, 2013

    Report

    Report Number
    0001825034-2013-00120
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MDM
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED AS LIMITED INFORMATION WAS AVAILABLE: PRODUCT IDENTIFICATION & EXPIRY DATE. MANUFACTURE DATE. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. SURGICAL TECHNIQUE WAS UPDATED AND NOW STATES "THE MEASUREMENTS SPECIFIED WITH THE PROXIMAL BODIES ARE DEFINED AS THE DISTANCE FROM THE CENTER OF THE ANATOMIC NECK TO THE RESECTION LEVEL. IF USING AN INTERCALARY SEGMENT, THE AMOUNT OF ADDITIONAL RECONSTRUCTION REQUIRED IS LABELED. FOR EXAMPLE, A 30 MM SEGMENT ADDS 30 MM TO THE TOTAL."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A PROXIMAL HUMERAL REPLACEMENT PROCEDURE ON (B)(6) 2012. DURING THE TRIALING PROCESS OF THE PROCEDURE IT WAS UNKNOWN TO THE SURGEON THAT THE TRIAL TO STEM TAPER ADAPTER ADDED 30MM TO THE CONSTRUCT. AFTER THE ACTUAL IMPLANTS WERE ASSEMBLED IT WAS NOTICED THE CONSTRUCT WAS 30MM SHORT AND DID NOT ADEQUATELY MATCH PATIENT'S ANATOMY. SUBSEQUENTLY, THE SURGEON USED A DIFFERENT SIZED IMPLANT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25999 COMPRESS SEGMENTAL REVISION SYSTEM STEM TO TRIAL ADAPTER DEVICE, PROSTHESIS ALIGNMENT MDM BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R