BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ELBOW

    MDR report key: 4200542 · Received October 24, 2014

    Report

    Report Number
    0001825034-2014-08222
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(6). THE 510K NUMBER - UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON AN ARTICLE RECEIVED, "FLEXOR CARPI ULNARIS MUSCLE FLAP FOR SOFT TISSUE RECONSTRUCTION AFTER TOTAL ELBOW ARTHROPLASTY," WHICH REPORTS THE POSITIVE CLINICAL RESULTS THE AUTHORS EXPERIENCED BY USING A FLEXOR CARPI ULNARIS (FCU) MUSCLE FLAP FOR SOFT TISSUE RECONSTRUCTION. THE STUDY FOLLOWED TWO PATIENTS WHO UNDERWENT TOTAL ELBOW ARTHROPLASTY; ONLY ONE OF THE TWO PATIENTS RECEIVED A BIOMET ELBOW IMPLANT. THE JOURNAL ARTICLE REPORTS THAT IMMEDIATELY AFTER THE TOTAL ELBOW ARTHROPLASTY, BLISTERING OCCURRED ON THE TIP OF THE OLECRANON. AN AREA OF SKIN NECROSIS OCCURRED TWO WEEKS AFTER SURGERY. THE PATIENT UNDERWENT A RECONSTRUCTION USING THE FCU MUSCLE FLAP AND NO POSTOPERATIVE COMPLICATIONS WERE REPORTED. THE AUTHORS CONCLUDE THAT THE FCU MUSCLE FLAP IS THE LEAST INVASIVE TREATMENT AND SHOULD BE SELECTED FIRST (ABOVE OTHER MUSCLES) WHEN RECONSTRUCTING SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678834 UNKNOWN ELBOW PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R