BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -6MM NK

    MDR report key: 4047562 · Received August 29, 2014

    Report

    Report Number
    0001825034-2014-07428
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 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
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES,"INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE IMPLANTED - (B)(6) 2002. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 11-173660, LOT NUMBER - 321200, EXPIRATION DATE - APR 30, 2012, MANUFACTURE DATE ¿ APR 10, 2002. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 11-173662, LOT NUMBER - 145750, EXPIRATION DATE - OCT 31, 2012, MANUFACTURE DATE ¿ OCT 11, 2002.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN SIDE ON (B)(6) 2002 AND A TOTAL HIP ARTHROPLASTY ON THE OTHER SIDE ON (B)(6) 2002. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN SIDE ON (B)(6) 2014 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530238 M2A 38MM MOD HD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R