BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD +9MM

    MDR report key: 3122574 · Received May 21, 2013

    Report

    Report Number
    0001825034-2013-01583
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01582 / 01583).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO INFECTION. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225046 36MM COCR MOD HD +9MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 086580

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R