BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3996486 · Received August 8, 2014

    Report

    Report Number
    1526439-2014-11732
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. HETTRICH, C., ET AL LOCKED PLATING OF THE PROXIMAL HUMERUS USING AN ENDOSTEAL IMPLANT JOURNAL OF ORTHOPAEDIC (2012)26:212-215. THIS REPORT IS FOR UNKNOWN 3.5-MM LCP HUMERAL PLATE. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LOCKED PATING OF THE PROXIMAL HUMERUS USING AN ENDOSTEAL IMPLANT. CAROLYN M. HETTRICH, ET AL. (2012) JOURNAL OF ORTHOPEDIC TRAUMA 26:212-215. THIS WAS A PROSPECTIVE STUDY THAT INCLUDED THE CHART REVIEW OF 31 PATIENTS WITH PROXIMAL HUMERUS FRACTURES AND WHO UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH ENDOSTEAL AUGMENTATION BETWEEN NOVEMBER 2006 AND AUGUST 2008. THE PURPOSE OF THE STUDY WAS TO REPORT ON THE USE OF A SUPPLEMENTAL MEDIAL ENDOSTEAL IMPLANT TO REPREVENT VARUS COLLAPSE AND SCREW CUTOUT PROXIMAL HUMERUS FRACTURES TREATED WITH A LATERALLY PLACED LOCKING PLATE. OF THE 31 PATIENTS, 4 PATIENTS WERE LOST TO FOLLOW-UP. OF THESE 4 PATIENTS, 2 DIED OF UNRELATED CAUSES BEFORE THE 6 MONTH FOLLOW-UP PERIOD. THE MEAN AGE OF PATIENTS WAS 65 +/- 9.9 YEARS OLD AND THE AVERAGE FOLLOW-UP WAS 63.1 WEEKS. A 3.5-MM LCP PROXIMAL HUMERUS PLATE (SYNTHES, (B)(4)) WITH A MEDIAL ENDOSTEAL IMPLANT (BIBULAR ALLOGRAFT IN 23 PATIENTS AND SEMITUBULAR PLATE IN 4 PATIENTS) WERE USED FOR FIXATION. TWENTY-SIX OF THE 27 PATIENTS MAINTAINED THEIR ORIGINAL REDUCTION WITH AN AVERAGE LOSS OF HEIGHT OF 1.2 MM AND AN AVERAGE CHANGE IN SHAFT-HEAD ANGLE BY 2,2 DEGREES. THERE WERE NO IMPLANT FAILURES OR SCREW PERFORATIONS OF THE ARTICULAR SURFACE AND NO RADIOGRAPHIC OR CLINICAL EVIDENCE OF AVASCULAR NECROSIS (AVN). IN THE 27 PATIENTS WITH COMPLETE FOLLOW-UP, 1 PATIENT HAD AN INFECTION. THERE WERE NO IDENTIFIABLE PATIENTS. THIS REPORT IS FOR AN UNKNOWN 3.5-MM LCP HUMERUS PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472360 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention