BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLET

    MDR report key: 3114390 · Received May 15, 2013

    Report

    Report Number
    0001825034-2013-01524
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    EKD
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION INDICATES THE USE OF INCORRECT INSTRUMENTATION CAUSED THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THERE ARE WARNINGS IN THE ASSOCIATED PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT STATES, "SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01508 & 01524).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. A SUBSEQUENT REVISION WAS PERFORMED ON (B)(6) 2013 DUE TO UNKNOWN REASONS. WHILE THE SURGEON WAS ATTEMPTING TO REMOVE THE HEAD WITH A MALLET, THE HEAD BECAME COLD WELDED TO THE STEM RESULTING IN A DELAY OF OVER TWO HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215223 MALLET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT EKD BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R