BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02983

    MDR report key: 3139594 · Received May 31, 2013

    Report

    Report Number
    2520274-2013-02983
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    ARTICLE TITLED: LOCKING PLATE FIXATION OF FRACTURES OF THE PROXIMAL HUMERUS: ANALYSIS OF COMPLICATIONS, REVISION STRATEGIES AND OUTCOME. AUTHORS: BERNHARD JOST, MD, CHRISTIAN SPROSS, MD, HOLGER GREHN, MD,CHRISTIAN GERBER, MD, FRCSED (HON). BETWEEN JANUARY 2003 AND SEPTEMBER 2010, 121 PATIENTS WITH COMPLICATIONS AFTER OPEN REDUCTION AND LOCKING PLATE FIXATION OF A FRACTURE OF THE PROXIMAL HUMERUS WERE CONSECUTIVELY COLLECTED. THERE WERE 67 WOMEN AND 54 MEN. THE MEAN AGE OF 59 YEARS WERE REFERRED AFTER PRIMARY LOCKING PLATE ORIF (PHILOS PROXIMAL HUMERUS INTERLOCKING PLATE SYSTEM SYNTHES, PAOLI, PA, USA) WAS USED IN ALL 121 PATIENTS. A MEAN OF 3 COMPLICATIONS OCCURRED PER PATIENT, INCLUDING MALREDUCTION, PRIMARY SCREW CUTOUT, MALUNION, NONUNION, AVASCULAR NECROSIS, AND INFECTION. COMPLICATIONS RESULTED IN SECONDARY ARTHROPLASTIES IN OVER 50 PERCENT OF THE PATIENTS. ALL PATIENTS HAD RESTRICTED SHOULDER FUNCTION BECAUSE OF PAIN OR LOSS OF PASSIVE AND ACTIVE SHOULDER MOBILITY (OR BOTH), EVEN AFTER REVISION SURGERY. THE 121 PATIENTS WERE FIRST SEEN AFTER A MEAN OF 15 MONTHS AFTER ORIF HUMERUS. ONE HUNDRED SIXTEEN PATIENTS COMPLAINED OF PAIN AND 101 PATIENTS HAD RESTRICTED ELEVATION RESTRICTION OF LESS THAN 90 DEGREES. THIS COMPLAINT REPRESENTS 121 PATIENTS. THIS ARTICLE IS FROM JOURNAL OF SHOULDER AND ELBOW SURGERY. COPYRIGHT 2013 JOURNAL OF SHOULDER AND ELBOW SURGERY BOARD OF TRUSTEES. PAGES 542-549 HTTP://DX.DOI.ORG/10.1016/J.JSE.2012.06.008 PLEASE NOTE: THE ARTICLE NOTES THIS STUDY HAS SEVERAL LIMITATIONS. FIRST, BECAUSE OF THE NEGATIVE SELECTION BIAS FOR PATIENTS WITH COMPLICATIONS, IT CANNOT GENERALIZE AND ADDRESS THE VALUE OF THE LOCKING PLATE. SECOND, THERE IS A POSSIBLE BIAS IN THE INITIAL FRACTURE CLASSIFICATION. OVERALL, THERE EXISTS NO RELIABLE AND REPRODUCIBLE FRACTURE CLASSIFICATION. WE HAVE CHOSEN THE NEER CLASSIFICATION SYSTEM, WHICH IS FREQUENTLY USED AMONG SHOULDER SURGEONS AND HAS BEEN SHOWN TO BE SUPERIOR TO, FOR EXAMPLE, THE AO CLASSIFICATION.24 THIRD, THE SCORING SYSTEM OF THIS STUDY IS NOT COMPLETE AND UNIFORM, BECAUSE CS AND SSV WERE ONLY CONSISTENTLY DOCUMENTED IN PATIENTS WITH SECONDARY ARTHROPLASTY. THIS REPORT IS #2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241950 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention