BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4689815 · Received April 14, 2015

    Report

    Report Number
    2520274-2015-12595
    Event Type
    Injury
    Date Received
    April 14, 2015
    Report Date
    March 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOUDARD, G., ET AL (2014). LOCKING PLATE FIXATION VERSUS ANTEGRADE NAILING OF 3- AND 4-PART PROXIMAL HUMERUS FRACTURES IN PATIENTS WITHOUT OSTEOPOROSIS. COMPARATIVE RETROSPECTIVE STUDY OF 63 CASES. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 100, 917¿924. THIS REPORT IS FOR AN UNKNOWN PHILOS PLATE SYSTEM. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, BOUDARD, G., ET AL (2014). LOCKING PLATE FIXATION VERSUS ANTEGRADE NAILING OF 3- AND 4-PART PROXIMAL HUMERUS FRACTURES IN PATIENTS WITHOUT OSTEOPOROSIS. COMPARATIVE RETROSPECTIVE STUDY OF 63 CASES. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 100, 917¿924. THE GOAL OF THIS RETROSPECTIVE OBSERVATIONAL STUDY WAS TO COMPARE FUNCTIONAL AND RADIOLOGICAL RESULTS AND COMPLICATIONS OF INTERNAL FIXATION USING LOCKING PLATES VERSUS ANTEGRADE NAILING IN THE TREATMENT OF NON-OSTEOPOROTIC NEER CLASSIFICATION 3- AND 4-PART FRACTURES AFTER A LEAST 1 YEAR OF FOLLOW-UP. INTERNAL FIXATION WAS PERFORMED IN 67 FRACTURES (1 BILATERAL): 35 BY LOCKING PLATE (1 LOST TO FOLLOW-UP, 1 DECEASED) AND 32 BY INTRAMEDULLARY NAILING (2 LOST TO FOLLOW-UP) BETWEEN JANUARY 1ST, 2004 AND DECEMBER 31ST, 2010. THUS, THE STUDY INCLUDED 33 PLATES (21 3-PART AND 12 4-PARTFRACTURES) AND 30 NAILS (21 3-PART AND NINE 4-PART FRACTURES). FIXATION USED INCLUDED LOCKING PLATES ONLY IN ONE HOSPITAL UNIT, (SYNTHES PHILOS (PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM) PLATES OR THE PLATES OF A COMPETITOR) AND IN THE OTHER UNIT INTRAMEDULLARY PROXIMAL HUMERUS NAILS ONLY. MEAN FOLLOW-UP IN THE LOCKING PLATE GROUP WAS 24.7 ± 19.9 MONTHS AND INCLUDED 33 FRACTURES, WITH TWO THAT WERE BILATERAL. THE MEAN AGE OF THE 32 PATIENTS WAS 49.6 ± 17.5 YEARS OLD. PATIENTS UNDERWENT CLINICAL AND RADIOGRAPHIC FOLLOW-UP AT 6 WEEKS, 3 MONTHS, 12 MONTHS THEN LATER DEPENDING ON OUTCOME AND COMPLICATIONS. POSTOPERATIVE RESULTS IN THE LOCKING PLATE GROUP WERE UNSATISFACTORY REDUCTION ON INITIAL AP (15.2%) OR LATERAL (6.1 %) X-RAYS, UNSATISFACTORY REDUCTION ON FOLLOW-UP AP (30.3%) OR LATERAL (3.2%) X-RAYS, SECONDARY DISPLACEMENT ON AP (¿4.2¿), OR LATERAL (¿1.5¿) X-RAYS, UNSATISFACTORY REDUCTION OF THE GREATER TUBEROSITY (9.1%), AVASCULAR NECROSIS OF THE HUMERAL HEAD (21.2%), AND A NON-UNION OF THE GREATER TUBEROSITY (3.0%). COMPLICATIONS INCLUDED TYPE 1 COMPLEX REGIONAL PAIN SYNDROME 33.3%, SUBACROMIAL IMPINGEMENT 15.2%, INFECTION 9.1%, ROTATOR CUFF TENDON TEAR 6%, AND REVISION WITH REMOVAL OF SURGICAL HARDWARE 30.3%. PATIENT 3 (AGE 17) UNDERWENT REMOVAL OF SURGICAL HARDWARE (RSH) REVISION SURGERY. PATIENT 11 (AGE 49) UNDERWENT RSH-SPACER-REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) DUE TO COMPLETE NECROSIS/INFECTION). PATIENT 21 (AGE 52) UNDERWENT RSH DUE TO SUBACROMIAL IMPINGEMENT DUE TO PLATE (SAI). PATIENT 22 (AGE 17) UNDERWENT RSH DUE TO SAI DUE TO PLATE. PATIENT 24 (AGE 23) UNDERWENT RSH DUE TO SAI DUE TO PLATE. PATIENT 25 (AGE 28) UNDERWENT RSH DUE TO COMPLETE NECROSIS AND SCREW PROTRUSION. PATIENT 28 (AGE 67) UNDERWENT RSH-SPACER-RTSA DUE TO PARTIAL NECROSIS OF THE GREATER TUBEROSITY AND INFECTION. PATIENT 30 (AGE 31) UNDERWENT RSH DUE TO SAI DUE TO PLATE. PATIENT 31 (AGE 49) UNDERWENT RSH, ARTHROSCOPY, ACROPIOPLASTY, REINSERTION OF THE SUPRASPINATUS TENDON DUE TO SAI DUE TO PLATE, PARTIAL NECROSIS OF THE GREATER TUBEROSITY, AND FAILED SUPRASPINATUS REPAIR. PATIENT 32 (AGE 54) UNDERWENT RSH-SPACER-RTSA DUE TO COMPLETE NECROSIS AND INFECTION. ONE PATIENT WAS DECEASED ON FOLLOW-UP. THIS REPORT IS FOR AN UNKNOWN PHILOS PLATE SYSTEM. THIS IS REPORT 7 OF 11 FOR COMPLAINT (B)(4). A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS MEDWATCH REFERS TO PATIENT 25 (AGE 28) UNDERWENT RSH DUE TO COMPLETE NECROSIS AND SCREW PROTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248456 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention