BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX54MM

    MDR report key: 4200715 · Received October 24, 2014

    Report

    Report Number
    0001825034-2014-08359
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    May 23, 2014
    Report Date
    November 6, 2014
    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
    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. 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.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05605 AND 08359).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE MATERIAL ANALYSIS, IT WAS NOTED THE COMPONENT SHOWED EVIDENCE OF SUBLUXATION OF THE JOINT, SCRATCHING OF THE BEARING SURFACES AND MINOR TAPER FRETTING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 ALLEGEDLY DUE TO ADVERSE REACTION TO METAL DEBRIS AND PERSONAL INJURY. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680175 M2A 1 PC SHELL 38MMX54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 818410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R