BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS 12MM LS TIBIAL BEARING

    MDR report key: 3843966 · Received June 2, 2014

    Report

    Report Number
    0001825034-2014-05126
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK021260
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. 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." THIS REPORT IS NUMBER 6 OF 12 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05121/05132).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE SYSTEM PROCEDURE ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. DURING THE REVISION PROCEDURE, ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321571 OSS RS 12MM LS TIBIAL BEARING PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 577500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R