BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL NC 16X160

    MDR report key: 4093611 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07728
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 NUMBER 1 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-07728 /-07729 /-07730 /-07731 /-07732).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013 AND RECEIVED A TAPERLOC HIP. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO INFECTION. ALL PRODUCTS WERE REMOVED AND REPLACED WITH A SPACER MOLDS. ON (B)(6) 2014, THE SPACER MOLDS WERE REMOVED AND REPLACED WITH AN ECHO BI-METRIC STEM AND A MAGNUM TRI-SPIKE CUP. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO DISLOCATION. THIS DISLOCATION WAS A RESULT OF THE VERSION (ROTATION) OF THE ECHO STEM. THE STEM, MODULAR HEAD, AND ACTIVE ARTICULATION POLY WERE REMOVED AND REPLACED WITH AN ARCOS STEM AND HEAD. REVIEW OF INVOICE HISTORY VERIFIED THE IMPLANT AND REVISION SURGERY DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573759 ECHO POR FMRL NC 16X160 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 523000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R