BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS 5CM TAPER ADAPTER

    MDR report key: 2832045 · Received November 14, 2012

    Report

    Report Number
    0001825034-2012-02347
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK041352
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 7 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02347 & 02422).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010 DUE TO FRACTURED BONE, AND TO REPLACE AND ROTATE IMPLANTS. FURTHER, PATIENT WAS AGAIN REVISED ON (B)(6) 2012 DUE TO TAPER ADAPTER FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESS 5CM TAPER ADAPTER PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 643140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R