BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN S3 SHOULDER PLATE

    MDR report key: 3910787 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05934
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    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. IT IS NOT KNOWN WHETHER THE PATIENTS WHO EXPERIENCED POOR RESULTS OR PRESENTED WITH AVASCULAR NECROSIS WERE IMPLANTED WITH THE DEPUY MANUFACTURED CONVENTIONAL PLATES. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN, EXPIRATION DATE - UNKNOWN, DATE IMPLANTED - UNKNOWN, DATE EXPLANTED - UNKNOWN, INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY V.L. RUSIMOV IN OSTEOPOROS INTERNATIONAL (2014) 25 (SUPPL 2): S1 59-S440, MANUFACTURE DATE ¿ UNKNOWN. DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "TREATMENT OF UNSTABLE OSTEOPOROTIC FRACTURES OF PROXIMAL HUMERUS WITH LOCKING PLATES" WHICH COMPARED SURGICAL TREATMENT OF FRACTURES UTILIZING LOCKING PLATES VERSUS CONVENTIONAL PLATES. THE STUDY WAS CONDUCTED OVER A PERIOD OF FIVE YEARS (2005-2010) AND INVOLVED TWENTY-THREE (23) PATIENTS. TEN (10) OF THE PATIENTS RECEIVED CONVENTIONAL PLATES (S3 PLATES) MANUFACTURED BY DEPUY ORTHOPEDICS. THIRTEEN (13) OF THE PATIENTS RECEIVED LOCKING PLATES (LPHP PLATES) MANUFACTURED BY A COMPETITOR. THE JOURNAL ARTICLE REPORTS, AFTER A MINIMUM FOLLOW-UP TIME OF 3 YEARS, 14 (60.9%) PATIENTS HAD EXCELLENT AND GOOD RESULTS, 9 (39.1%) HAD SATISFACTORY RESULTS, AND 2 (8.7%) HAD POOR RESULTS. AVASCULAR NECROSIS WAS PRESENT IN 2 (8.7%) PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386863 UNKNOWN S3 SHOULDER PLATE PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention