BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5675415 · Received May 24, 2016

    Report

    Report Number
    2520274-2016-12808
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    June 18, 2015
    Report Date
    May 17, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN LISS PLATE, UNKNOWN LOT NUMBER. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    LITERATURE ARTICLE RECEIVED. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: BOESMUELLER, S. ET AL. (2015). PLATE FAILURE FOLLOWING PLATE OSTEOSYNTHESIS IN PERIPROSTHETIC FEMORAL FRACTURES. WIEN KLIN WOCHENSCHR. 127:770-778. THE AIM OF THIS RETROSPECTIVE STUDY IS TO INVESTIGATE THE PATIENTS' OUTCOMES AFTER PLATE FAILURE. SEVEN OUT OF 80 PATIENTS TREATED WITH PLATE OSTEOSYNTHESIS FOLLOWING PERIPROSTHETIC FEMORAL FRACTURES (PPFF) BETWEEN JANUARY 2000 AND JUNE 2010 MET INCLUSION CRITERION. ALL SEVEN PATIENTS SUFFERING FROM A REFRACTURE WERE FEMALE, WITH AN AVERAGE AGE OF 74 (RANGE, 49-88) AT INITIAL SURGERY. PATIENT 3: FEMALE, (B)(6) YEAR-OLD: NONHEALING OF THE BONE FORCED THE PLATE BREAKAGE OF THE LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE (DEPUY SYNTHES, (B)(4)). PATIENT WAS REVISED WITH A 9-HOLE LC-DCP. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN LISS PLATE AND REFERS TO PLATE BREAKAGE WITH THE SERIOUS INJURY OF NONUNION AND REVISION SURGERY. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329843 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention