BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED HEAD-6MM

    MDR report key: 4221946 · Received November 3, 2014

    Report

    Report Number
    0001825034-2014-08487
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07955 & 08487).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO INFECTION; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THE INVOICE HISTORY COULD NOT BE REVIEWED DUE TO LIMITED INFORMATION RECEIVED. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH COMPETITOR PRODUCT. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO AN UNKNOWN REASON AND UNDERWENT AN EXTENDED TROCHANTERIC OSTEOTOMY TO SECURE THE FEMORAL STEM. ALL COMPONENTS WERE REMOVED AND A BIOMET TOTAL HIP SYSTEM AND CABLES WERE IMPLANTED. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2014 DUE TO DISLOCATION. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701893 FREEDOM CONSTRAINED HEAD-6MM PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 318760

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R