BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 4200695 · Received October 24, 2014

    Report

    Report Number
    0001825034-2014-08327
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    January 18, 2012
    Report Date
    April 13, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, IT STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ AND ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ AND ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ AND ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08327 & -09311).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, METAL POISONING, FATIGUE, AND AN AFFECTED GAIT. REVIEW OF INVOICE RECORDS INDICATES THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 DUE TO METAL ON METAL WEAR WITH OSTEOLYSIS. OPERATIVE REPORT NOTED THE PRESENCE OF REACTIVE SYNOVITIS, CREAMY EXUDATE CONSISTENT WITH METALLOSIS, METAL ON METAL WEAR, CORROSION ON THE TAPER AND CAVITARY LESIONS IN THE ANTERIOR INFERIOR ASPECT OF THE ACETABULUM. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, METAL POISONING, FATIGUE, AND AN AFFECTED GAIT. REVIEW OF INVOICE RECORDS INDICATES THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. 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

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, METAL POISONING, FATIGUE, AND AN AFFECTED GAIT. 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
    679315 M2A 38MM MOD HD +3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 179590

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R