BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 4175688 · Received October 15, 2014

    Report

    Report Number
    0001825034-2014-08066
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - UNKNOWN; BRAND NAME - UNKNOWN; CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - UNKNOWN; DATE EXPLANTED - UNKNOWN; INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY HAKAN SESEN, MD ET AL; KNEE SURG SPORTS TRAUMATOL ARTHROSCOPY, DOI 10.1007/S00167-014-3251-7, EUROPEAN SOCIETY OF SPORTS TRAUMATOLOGY, KNEE SURGERY, ARTHROSCOPY (ESSKA) 2014; 510K NUMBER - UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "WHY TWO-THIRDS OF PATIENTS ACCEPTED THE SECOND SESSION IN STAGED BILATERAL TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE ANALYSIS OF 111 PATIENTS,¿ WHICH EVALUATED POSTOPERATIVE PATIENT EXPECTATIONS AND CLINICAL OUTCOMES AS WELL AS TO EVALUATE THE RATE OF SECOND STAGE IN BILATERAL STAGED TKA. THE STUDY WAS CONDUCTED OVER A PERIOD OF TWO (2) YEARS (MARCH 2010 THROUGH APRIL 2012) AND FOLLOWED ONE-HUNDRED ELEVEN (111) PATIENTS WHO UNDERWENT STAGED TOTAL KNEE ARTHROPLASTY PROCEDURES. FORTY-ONE (41) PATIENTS REFUSED THE SECOND STAGE PROCEDURE. THE JOURNAL ARTICLE CONCLUDED THAT THE EXPECTATIONS FOR SURGERY ARE MET IN THE MAJORITY OF PATIENTS. POSTOPERATIVE PERCEPTION OF HEALTHCARE AND THE KNOWLEDGE AND RESPONSIVITY OF THE TREATING SURGEON WERE THE MAJOR CONCERNS FOR PATIENTS CONSIDERING SECOND STAGE TKA. FUNCTIONAL OUTCOME MEASURES ALSO HAVE VALUE IN GUIDING THE PATIENT TOWARDS A DECISION FOR THE SECOND STAGE. RECOGNIZING PATIENTS¿ EXPECTATIONS AND NEEDS AFTER THE INDEX SURGERY WILL INFLUENCE THE RATE OF SECOND-STAGE SURGERY IN AN AGING POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655386 UNKNOWN KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R