BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX52MM CUP

    MDR report key: 3782001 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03389
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    September 26, 2012
    Report Date
    June 10, 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
    TX, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." CORRECTED DATE: EVENT DESCRIPTION-DATE OF RIGHT THA. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03388 /-03389 /-05710).

    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 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ 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 NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03388/ 03389).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2014. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DEBILITATION, ELEVATED METAL ION LEVELS, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METAL POISONING, AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO PATIENT'S RIGHT HIP TO DATE. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT HIP REVISION ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DEBILITATION, ELEVATED METAL ION LEVELS, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, LACK OF MOBILITY, METAL POISONING, AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO PATIENT'S RIGHT HIP TO DATE. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT HIP REVISION ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE (B)(6) 2012 REVISION OPERATIVE REPORT NOTED THE RIGHT HIP WAS REVISED AND THE PRESENCE OF WEAR DEBRIS AND METALLOSIS FRAGMENTS. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. NO INFORMATION RELATED TO THE LEFT HIP HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260681 M2A 38MMX52MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 704080

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R