BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX48MM CUP

    MDR report key: 3874438 · Received June 16, 2014

    Report

    Report Number
    0001825034-2014-05527
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    October 31, 2005
    Report Date
    June 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 4 STATES, ¿ LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02736 / -02739 AND -05526 / -05527).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, BONE/TISSUE DAMAGE, DIFFICULTY WALKING AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2012 AND (B)(6) 2012. THE MODULAR HEAD, ACETABULAR CUP, AND TAPER ADAPTER WERE REMOVED AND REPLACED ON (B)(6) 2012. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED ON (B)(6) 2012. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S MEDICAL RECORD DATED (B)(6) 2012 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP DUE TO LOOSENING. INFORMATION RECEIVED IN PATIENT¿S MEDICAL RECORD DATED (B)(6) 2012 REPORTS PATIENT WAS REVISED DUE TO RECURRENT RIGHT HIP DISLOCATION. MEDICAL RECORD FURTHER REPORTS ABDUCTOR MUSCLE DISRUPTION AS THE PRIMARY REASON FOR DISLOCATION. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORD REPORTS THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353089 M2A 38MMX48MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 316010

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization