BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM M2A MOD HEAD -6MM NK

    MDR report key: 3181692 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02128
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02107 / 02108 & 2128).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013, DUE TO DISASSOCIATION OF THE LINER. THE CUP AND LINER WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT AND THE HEAD WAS REMOVED AND REPLACED WITH BIOMET PRODUCT. METALLOSIS WAS NOTED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282109 28MM M2A MOD HEAD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 659440

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R