BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TPR INSRT STD

    MDR report key: 3971267 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06656
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 5, 2005
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS. " THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04519 /-04160 /-04166 /-04167 /-06656).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, LACK OF MOBILITY AND DAMAGE TO BONE/TISSUE. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURES OF THE LEFT HIP ON (B)(6) 2005 AND (B)(6) 2007. THERE HAS BEEN NO REPORTED REVISION OF THE RIGHT HIP TO DATE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE (B)(6) 2007 REVISION PROCEDURE. INVOICE HISTORY FURTHER INDICATES THAT THE MODULAR HEAD AND TAPER ADAPTER FROM THE LEFT HIP WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2005 DUE TO DISLOCATIONS. OPERATIVE REPORT NOTED THE CUP WAS VERTICAL AND RETROVERTED AND THE STEM WAS RETROVERTED. THE ACETABULAR CUP AND STEM WERE REMOVED, REINSERTED AND REPOSITIONED. THE SAME HEAD WAS REIMPLANTED. THE TAPER ADAPTER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446383 M2A-MAGNUM 42-50 TPR INSRT STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 684750

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R