BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX54MM CUP

    MDR report key: 3123539 · Received May 22, 2013

    Report

    Report Number
    0001825034-2013-01601
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    December 17, 2012
    Report Date
    April 23, 2013
    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
    PHYSICIAN

    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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01601 / 01602).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012, DUE TO ELEVATED METAL LEVELS, PSEUDOCYST, AND CHRONIC EFFUSION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225752 M2A 38MMX54MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 362250

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R