BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTR. LINER +5 SZ 24

    MDR report key: 3023540 · Received March 27, 2013

    Report

    Report Number
    0001825034-2013-00750
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    June 25, 2006
    Report Date
    February 27, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "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 5 OF 11 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00746 / 00756).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2004 TO ADD A CONSTRAINING RING ON THE CUP, NO REVISION OCCURRED. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2005 ALLEGEDLY DUE TO DISLOCATION. THE HEAD, CUP AND RING WERE REMOVED AND REPLACED WITH BIOMET PRODUCT. ON (B)(6) 2006 PATIENT UNDERWENT A SECOND REVISION ALLEGEDLY DUE TO DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED WITH BIOMET PRODUCT. ON (B)(6) 2012, PATIENT UNDERWENT A THIRD REVISION ALLEGEDLY DUE TO DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED WITH BIOMET PRODUCT. ON (B)(6) 2012, PATIENT UNDERWENT A FOURTH REVISION ALLEGEDLY DUE TO DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED WITH BIOMET PRODUCT. IT WAS FURTHER REPORTED THAT THE STEM ALLEGEDLY APPEARED EXCESSIVELY ANTEVERTED AND DISLOCATES OUT OF THE FRONT OF THE CUP. ON (B)(6) 2013, PATIENT WAS REVISED ALLEGEDLY DUE TO ELEVATED METAL IONS AND PAIN. THE HEAD AND LINER WERE REMOVED AND REPLACED WITH BIOMET PRODUCT AND THE CUP WAS REMOVED AND REPLACED WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125640 FREEDOM CONSTR. LINER +5 SZ 24 PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 058590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R