BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4624994 · Received March 23, 2015

    Report

    Report Number
    2520274-2015-11976
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Report Date
    February 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. AUDIGE, L., ET AL. (2009) ¿OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL HUMERUS FRACTURES USING A PROXIMAL HUMERAL LOCKED PLATE: A PROSPECTIVE MULTICENTER ANALYSIS.¿ JOURNAL OF ORTHOPAEDIC TRAUMA (2009; 23: 163-172). IT IS UNCLEAR FROM THE ARTICLE WHICH PATIENTS HAD A CT SCAN PERFORMED. THIS REPORT IS FOR AN UNKNOWN PHILOS /UNKNOWN QUANTITY/UNKNOWN LOT. (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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ¿OPEN REDUCTION AND INTERNAL FIXATION OF PROXIMAL HUMERUS FRACTURES USING A PROXIMAL HUMERAL LOCKED PLATE: A PROSPECTIVE MULTICENTER ANALYSIS.¿ (2009) AUDIGE, L., ET AL. JOURNAL OF ORTHOPAEDIC TRAUMA (2009; 23: 163-172). EUROPE ARTICLE. THIS IS A PROSPECTIVE CASE STUDY DESIGNED TO EVALUATE THE INCIDENCE OF COMPLICATIONS AND THE FUNCTIONAL OUTCOME AFTER OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH THE PROXIMAL HUMERAL 3 HOLE (86%) OR 5 HOLE LOCKING PLATE (PHILOS). THE STUDY SPECIFICALLY LOOKED AT THE RATE OF UNION, FUNCTIONAL OUTCOMES AND COMPLICATION INCIDENCE PROPORTIONS AFTER 1 YEAR FOLLOWING FIXATION OF THE PROXIMAL HUMERUS FRACTURE WITH PHILOS. EIGHT PARTICIPATING TRAUMA UNITS WERE INCLUDED IN THIS STUDY IN WHICH THERE WERE 157 PATIENTS WITH 158 PROXIMAL HUMERUS FRACTURES WHOM WERE RECRUITED BETWEEN SEPTEMBER 12, 2002 AND JANUARY 9, 2005, 1 PATIENT HAD A BILATERAL FRACTURE. THE MEAN PATIENT AGE WAS 65 YEARS (RANGE: 19-94 YEARS); 111 OF THE PATIENTS WERE WOMEN. THE PLATES UTILIZED WERE BASED ON FRACTURE EXTENSION. PLATES WERE PLACED AT LEAST 5-8MM INFERIOR TO THE UPPER END OF THE GREATER TUBEROSITY TO AVOID SUBACROMIAL IMPINGEMENT AND 2-4MM LATERAL TO THE BICIPITAL GROOVE, ENSURING THAT A SUFFICIENT GAP WAS MAINTAINED BETWEEN THE PLATE AND THE TENDON OF THE LONG HEAD OF THE BICEP MUSCLE. THE PLATE WAS FIXED WITH LOCKED AND/OR CORTICAL SCREWS. ADDITIONAL IMPLANTS WERE EMPLOYED IN 19 OF THE FRACTURES AND INCLUDED MOSTLY PLATE-INDEPENDENT SCREWS. ADDITIONAL SUTURES WERE WIDELY USED EITHER TO FIX A DISPLACED TUBEROSITY OR TO REGAIN ROTATOR CUFF INTEGRITY. THE PATIENTS WERE FOLLOWED FOR ONE YEAR AND HAD FOLLOW UPS AND RADIOLOGIC ASSESSMENT PERFORMED IMMEDIATELY POSTOPERATIVELY, AND AT 12 WEEKS, 6 MONTHS AND 12 MONTHS TO ASSESS OUTCOMES. COMPUTED TOMOGRAPHY (CT) EVALUATION WAS PERFORMED AT THE DISCRETION OF THE TREATING SURGEON. ONE YEAR FOLLOW UP RATE WAS 84%, 24 PATIENTS WERE LOST AT 1 YEAR FOLLOW UP AND INCLUDED 6 PATIENTS WHOM DIED OF UNRELATED CAUSES. THE INCIDENCE OF EXPERIENCING ANY IMPLANT-RELATED COMPLICATIONS WAS 9% AND 35% FOR NONIMPLANT-RELATED COMPLICATIONS. A COMPLICATION WAS CONSIDERED AS IMPLANT RELATED IF SCREWS PERFORATED SECONDARY TO ANGULAR STABILITY OR IF IMPLANT BREAKAGE, SECONDARY LOSS OF REDUCTION OR SCREW PULLOUT DUE TO INSUFFICIENT PURCHASE OCCURRED. PRIMARY SCREW PERFORATIONS WAS THE MOST FREQUENT PROBLEM (14%) FOLLOWED BY SECONDARY SCREW PERFORATION (8%) AND AVASCULAR NECROSIS (8%). OVERALL, 53 PATIENTS HAD AT LEAST ONE COMPLICATION, OFTEN A COMBINATION OF ASSOCIATED EVENTS, WHICH LEAD TO 39 UNPLANNED REOPERATIONS. ALL FRACTURES HEALED WITHIN 1 YEAR AND RATES OF OSTEONECROSIS AND SECONDARY LOSS OF REDUCTION WERE ONLY 8% AND 3% RESPECTIVELY. THE CONCLUSION IS THAT FIXATION WITH PHILOS PLATES PRESERVES ACHIEVED REDUCTION, AND GOOD FUNCTIONAL OUTCOME CAN BE EXPECTED. HOWEVER, COMPLICATION INCIDENCE PROPORTIONS ARE HIGH, PARTICULARLY DUE TO PRIMARY AND SECONDARY SCREW PERFORATIONS INTO THE GLENOHUMERAL JOINT, WITH AN OVERALL COMPLICATIONS RATE OF 35%. THIS REPORTS IS FOR AN UNKNOWN PHILOS PROXIMAL HUMERUS LOCKING PLATE AND REFERS TO:THERE WAS 12 PRIMARY SCREW PERFORATIONS WHICH DID NOT RESULT IN REOPERATION, 9 SECONDARY SCREW PERFORATIONS WHICH DID NOT RESULT IN REOPERATION, 1 PATIENT WHOM HAD SECONDARY SUBSIDENCE ASSOCIATED WITH PROXIMAL PLATE AND SCREW PULL OUT, 1 PATIENT WHOM HAD A SCREW BACK OUT WHICH DID NOT RESULT IN REOPERATION, 1 PATIENT WHOM HAD A 2-PART FRACTURE WITH METAPHYSEAL COMMINUTION DUE TO IMPLANT FATIGUE CAUSED BY THE MISSING MEDIAL SUPPORT AFTER 6 MONTHS. AFTER THE PLATE BROKE MEDIAL CONTACT WAS RESTORED AND THE FRACTURE HEALED IN MINOR VARUS DEVIATION WITH GOOD FUNCTIONAL OUTCOME. THERE WAS 1 PATIENT WHOM HAD DISTAL SCREW AND PLATE PULLOUT WHICH DID NOT RESULT IN REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192638 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1