BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX54MM CUP

    MDR report key: 3192262 · Received June 27, 2013

    Report

    Report Number
    0001825034-2013-02316
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    May 28, 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
    ATTORNEY

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - 2003. DATE EXPLANTED - 2003 . THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01000-1 & 02316/ 02317).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. SUBSEQUENTLY, LEGAL COUNSEL REPORTS PATIENT UNDERWENT A REVISION ON AN UNKNOWN DATE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT AN INITIAL PROCEDURE OF UNKNOWN PRODUCT OCCURRED ON AN UNKNOWN DATE. ON (B)(6) 2003, PATIENT WAS REVISED TO BIOMET PRODUCT DUE TO INFECTION. SUBSEQUENTLY, THE PATIENT WAS REVISED AGAIN IN 2003 DUE TO INFECTION. THE BIOMET MODULE HEAD, ACETABULAR CUP AND FEMORAL STEM WERE REMOVED AND AN ANTIBIOTIC ACETABULAR COMPONENT WAS PLACED IN THE PATIENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292971 M2A 38MMX54MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 319360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R