BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3955019 · Received July 24, 2014

    Report

    Report Number
    0001825034-2014-06426
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 10, 2014
    Report Date
    September 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. BRAND NAME - UNKNOWN; PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN ; DATE IMPLANTED - UNKNOWN; THE 510K NUMBER - UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PATIENT'S DATE OF BIRTH, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO POLY WEAR. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE REVISION PROCEDURE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE INITIAL PROCEDURE AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433993 UNKNOWN PROSTHESIS, HIP KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R