BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 36MM +3 MAXROM LNR SZ23

    MDR report key: 4053562 · Received September 3, 2014

    Report

    Report Number
    0001825034-2014-07475
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    June 25, 2012
    Report Date
    August 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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." AND "UNDESIRABLE SHORTENING OF LIMB." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01660 AND 2014-05411, 07474).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND THAT A SUBSEQUENT REVISION PROCEDURE OCCURRED ON (B)(6) 2012 DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION IN THE (B)(6) 2012 RIGHT HIP REVISION OPERATIVE REPORT NOTED THE REVISION WAS DUE TO PAIN AND FURTHER NOTED THE PRESENCE OF STRAW-COLORED CLOUDY FLUID. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER 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 NOTED PATIENT UNDERWENT AN ADDITIONAL RIGHT HIP REVISION ON (B)(6) 2013 DUE TO DISLOCATION AND A LEG LENGTH DISCREPANCY. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF METALLOSIS AND DEBRIS. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537053 E-POLY 36MM +3 MAXROM LNR SZ23 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 080800

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R