BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX48MM

    MDR report key: 2810018 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02277
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    January 21, 2013
    Report Date
    October 2, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE DATE OF THE REVISION PROCEDURE AND THE REASON FOR REVISION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02276-1 / 02277-1).

    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. THE CLINICAL SIGNIFICANCE OF THIS EFFECT IS UNCERTAIN, AS SIMILAR CHANGES MAY OCCUR AS A PRECURSOR TO OR DURING THE HEALING PROCESS. PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE EXPLANTED - N/A. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02276 / 02277). THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT ALLEGES ELEVATED METAL IONS AND FLUID BUILD UP. TO DATE, NO REVISION HAS BEEN PERFORMED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH BY PATIENT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT'S SPOUSE REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND THAT A REVISION PROCEDURE WAS NECESSARY DUE TO ALLEGED ELEVATED METAL IONS AND FLUID BUILDUP. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS CONFIRMS THE ELEVATED METAL IONS AND FLUID BUILDUP AND INDICATES THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 1 PC SHELL 38MMX48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 806300

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention