BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD

    MDR report key: 1183103 · Received October 3, 2008

    Report

    Report Number
    1825034-2008-00248
    Event Type
    Injury
    Date Received
    October 3, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND BEARING SURFACE EXHIBITED WEAR APPARENTLY DUE TO THIRD BODY ABRASIVE TRAPPED IN THE CLEARANCE. SOURCE OF THIRD BODY PARTICLES COULD NOT BE ESTABLISHED DURING VISUAL EXAMINATION. BASED ON THE APPEARANCE OF THE DEVICE, WEAR RATES DID NOT APPEAR TO BE EXCESSIVE. THIS REPORT FILED NOVEMBER 25, 2008

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR REVISION PROCEDURE DUE TO REPORTED PAIN. PRIOR TO THE REVISION PROCEDURE, THERE WAS AN UNCHARACTERISTIC LATE DISLOCATION OF HER CURRENT HIP PROSTHESIS. DURING THE REVISION PROCEDURE, IT WAS REPORTED THAT THERE WAS EVIDENCE OF A CLEAR TISSUE ABNORMALITY. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR REVISION PROCEDURE DUE TO REPORTED PAIN. PRIOR TO THE REVISION PROCEDURE, THERE WAS AN UNCHARACTERISTIC LATE DISLOCATION OF HER CURRENT HIP PROSTHESIS. DURING THE REVISION PROCEDURE, IT WAS REPORTED THAT THERE WAS EVIDENCE OF A CLEAR TISSUE ABNORMALITY. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM MODULAR HEAD PROSTHESIS, HIP COMPONENT KWA BIOMET INC. N/A 591630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R