BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -6MM NK

    MDR report key: 3232582 · Received July 18, 2013

    Report

    Report Number
    0001825034-2013-02723
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    February 26, 2004
    Report Date
    June 17, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 14 STATES "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01387 & 02723).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ENROLLED IN A (B)(4) STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. A SUBSEQUENT REVISION WAS PERFORMED ON (B)(6) 2008 DUE TO LYSIS, EFFUSION, AND PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336232 M2A 38MM MOD HD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 491880

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R