BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3683721 · Received March 18, 2014

    Report

    Report Number
    2520274-2014-10285
    Event Type
    Injury
    Date Received
    March 18, 2014
    Report Date
    February 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LOCKING PROXIMAL HUMERAL PLATE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ABSTRACT: FRANCO, D., MOON, C., PAIEMENT, G., AND SOLBERG, B. (2009). SURGICAL TREATMENT OF THREE AND FOUR-PART PROXIMAL HUMERAL FRACTURES. J BONE JOINT SURG AM., 91, 1689-97. THE AUTHORS RETROSPECTIVELY COMPARED THE OUTCOMES OF 122 PATIENTS WHO WERE TREATED BETWEEN 2002 AND 2005 WITH FIXED ANGLE LOCKED PLATES VERSUS HEMIARTHROPLASTY. THE FIXED ANGLE LOCKED PLATES GROUP INCLUDED LOCKED PROXIMAL HUMERAL PLATES MANUFACTURED BY SYNTHES (LPHP) AND TWO COMPETITORS. THE AUTHORS DID NOT IDENTIFY WHICH MANUFACTURER DEVICES WERE IMPLANTED IN THE STUDY PATIENTS. A TOTAL OF 38 PATIENTS WERE TREATED WITH A LOCKED PLATE CONSTRUCT COMPARED WITH 48 PATIENTS WITH HEMIARTHROPLASTY. AVERAGE FOLLOW-UP WAS 36 MONTHS. COMPLICATIONS INCLUDED: OSTEONECROSIS (SIX); LOSS OF FIXATION (FOUR WITH SUBSEQUENT CONVERSION TO HEMIARTHROPLASTY) AND WOUND INFECTION (THREE). THE AUTHORS CONCLUDED THAT DESPITE AN OVERALL HIGHER COMPLICATION RATES, THE LOCKED PLATE RESULTED IN BETTER OUTCOMES THAN DID HEMIARTHROPLASTY IN SIMILAR PATIENTS. PATIENTS WERE IMPLANTED WITH THE SYNTHES LPHP AND THE DEVICES OF TWO OTHER MANUFACTURERS. THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHICH DEVICE OF THE MANUFACTURERS WAS ASSOCIATED WITH EACH PATIENT; THEREFORE, THIS MEDWATCH IS BEING SUBMITTED FOR THE EVENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKED PROXIMAL HUMERAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158055 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention