BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5675642 · Received May 24, 2016

    Report

    Report Number
    2520274-2016-12822
    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 PLATE, UNKNOWN LOT. OTHER NUMBER: UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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.

    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. AUSTRIA AND GERMANY. 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 6: FEMALE, (B)(6): AFTER 4 MONTHS AFTER BEING PLATED WITH A 22-HOLE LOCKING COMPRESSION PLATE (LCP), TOPPED BY A SECOND 12-HOLE LCP (DEPUY SYNTHES, (B)(4)) PATIENT PRESENTED WITH PAIN IN RIGHT THIGH. RADIOGRAPHS SHOWED A FEMORAL SHAFT FRACTURE WITH PLATE BREAKAGE OF BOTH PLATES. THIS IS REPORT 4 OF 6 FOR (B)(4). THIS REPORT IS FOR UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331616 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention