BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POROUS FEMORAL RED NC 10X130 STEM

    MDR report key: 2944369 · Received February 5, 2013

    Report

    Report Number
    0001825034-2013-00245
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    August 16, 2012
    Report Date
    January 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS. NUMBER 14 STATES,"POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00240 / 00245).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PATIENT'S BLOOD TEST RESULTS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, OSTEOLYSIS, AND ELEVATED COCR LEVELS. THE HEAD, STEM AND TAPER INSERT WERE REMOVED AND REPLACED. FURTHER, PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2012 DUE PATIENT ALLEGATIONS OF DISLOCATION, PAIN AND ELEVATED COCR LEVELS. THE CUP, HEAD AND TAPER INSERT WERE REMOVED AND REPLACED WITH BIOMET TAPER ADAPTER AND HEAD AND COMPETITOR PRODUCT. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48924 ECHO POROUS FEMORAL RED NC 10X130 STEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 244630

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R