BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 60MM CUP NON FLARED

    MDR report key: 2587647 · Received May 24, 2012

    Report

    Report Number
    0001825034-2012-00672
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    April 12, 2012
    Report Date
    March 2, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INITIAL REPORTER AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION REGARDING PATIENT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    REVIEW OF EXPLANTED DEVICES FOUND THAT THE HEAD AND CUP APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES. THERE WAS POSSIBLE EVIDENCE OF CORROSION OR FRETTING WEAR ON THE HEAD TAPER. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER EIGHT STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING". THIS FOLLOW UP REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00672-1 / 00673-1).

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 FIFTEEN STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES". EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00672 / 00673).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012, DUE TO ELEVATED METAL ION LEVELS, PRESENCE OF A PSUEDOTUMOR, AND PAIN. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012, DUE TO ELEVATED METAL ION LEVELS. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-38 60MM CUP NON FLARED PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 363220

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R