BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II MOD ENDO HEAD SZ 46

    MDR report key: 3811795 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04052
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWL
    PMA / PMN Number
    PK984028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 10 STATES, ¿FRETTING AND CREVICE CORROSION CAN OCCUR AT INTERFACES BETWEEN COMPONENTS." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04052 / 04054).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014, DUE TO METALLOSIS, FLUID, AND DAMAGE TO MUSCLE. SURGEON COULD NOT REMOVE THE HEAD FROM THE STEM AS THEY WERE COLD WELDED. AS A RESULT, A DELAY OVER THIRTY (30) MINUTES WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290234 ENDO II MOD ENDO HEAD SZ 46 PROSTHESIS, HIP KWL BIOMET ORTHOPEDICS N/A 873430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R