BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3740400 · Received April 10, 2014

    Report

    Report Number
    0001825034-2014-02725
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    May 13, 2003
    Report Date
    April 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED AS LIMITED INFORMATION WAS AVAILABLE: PRODUCT IDENTIFICATION AND EXPIRY DATE; MANUFACTURE DATE. THIS REPORT IS NUMBER 2 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00639 AND 02725 / 02727).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON DEC 19, 1973. PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 1983 AND (B)(6) 2003 DUE TO UNKNOWN REASONS. IT WAS FURTHER REPORTED PATIENT UNDERWENT A FEMORAL REVISION PROCEDURE ON (B)(6) 2003. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON RIGHT HIP (B)(6) 2009 DUE TO ACETABULAR CUP LOOSENING AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216839 UNKNOWN PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R