BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 2991644 · Received March 6, 2013

    Report

    Report Number
    0001825034-2013-00507
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    May 2, 2011
    Report Date
    August 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00507 / 00508).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A REVISION ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, PROBLEMS SITTING, STANDING, DISLOCATION OF THE HIP, MOVING UP AND DOWN STAIRS, AND INFLAMMATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2011 DUE TO PAIN, ELEVATED METAL ION LEVELS AND SQUEAKING. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF SYNOVIAL FLUID WITH METAL PARTICLES AND AN OSTEOLYTIC LESION FILLED WITH METALLIC DEBRIS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR¿S CUP AND BIOMET HEAD.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A REVISION ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, PROBLEMS SITTING, STANDING, DISLOCATION OF THE HIP, MOVING UP AND DOWN STAIRS, AND INFLAMMATION. 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
    95144 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 550590

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R