BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AXLE

    MDR report key: 2820206 · Received November 6, 2012

    Report

    Report Number
    0001825034-2012-02355
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 ADVERSE EFFECTS NUMBER 16 STATES: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 4 OF 9 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02352/ 02360).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT ORTHOPAEDIC SALVAGE SYSTEM KNEE REVISION OF NON BIOMET PRODUCT IN (B)(6) 2011 FOR UNKNOWN REASON. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2012 DUE TO TIBIAL FRACTURE. ALL OSS PRODUCT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSS AXLE PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 131810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R