BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4330730 · Received December 15, 2014

    Report

    Report Number
    0001825034-2014-09135
    Event Type
    Injury
    Date Received
    December 15, 2014
    Report Date
    December 1, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE JOURNAL ARTICLE WAS REPORTED ON CMP0130982, MEDWATCH 1825034-2014-08242. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY M. VAN HEUMEN, P. J. C. HEESTERBEEK, B. A. SWIERSTRA, G. G. VAN HELLEMONDT, AND J. H. M. GOOSEN. J ORTHOPAED TRAUMATOL, DOI 10.1007/S10195-014-0318-7.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL THA ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A TWO STAGE REVISION ON UNKNOWN DATES DUE TO INFECTION. INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "DUAL MOBILITY ACETABULAR COMPONENT IN REVISION TOTAL HIP ARTHROPLASTY FOR PERSISTENT DISLOCATION: NO DISLOCATIONS IN 50 HIPS (49 PATIENTS, 10 MALE & 39 FEMALE) AFTER 1-5 YEARS¿. THE JOURNAL ARTICLE REPORTS THAT RE-REVISIONS AND/OR ADVERSE EVENTS OCCURRED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821462 UNKNOWN PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN LOT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R