BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II MOD ENDO HEAD SZ 54

    MDR report key: 3073409 · Received April 23, 2013

    Report

    Report Number
    0001825034-2013-01107
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK984028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01107/01108).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. THE ENDO HEAD AND TAPER WERE REMOVED AND REPLACED WITH ANOTHER ENDO HEAD AND TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175617 ENDO II MOD ENDO HEAD SZ 54 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 630160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R