BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T M/H RAD 2HL SHL 41/52MM

    MDR report key: 2918170 · Received January 16, 2013

    Report

    Report Number
    0001825034-2013-00122
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    October 10, 2012
    Report Date
    January 11, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. 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 WARNINGS, NUMBER 14 STATES: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02418, 02418-1, 1825034-2013-00121 - 00122). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT M2A TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY. A REVISION PROCEDURE WAS PERFORMED (B)(6) 2012 DUE TO ALLEGED PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24415 M2A-T M/H RAD 2HL SHL 41/52MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 799170

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R