BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3799333 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11266
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 23, 2014
    Manufacturer
    DEPUY 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SCHLIEMANN, B. ET AL. (2012). COMPLEX FRACTURES OF THE PROXIMAL HUMERUS IN THE ELDERLY-OUTCOME AND COMPLICATIONS AFTER LOCKING PLATE FIXATION. MUSCULOSKELET SURG SUPPL 1, 96, S3-S11. THIS REPORT IS FOR AN UNKNOWN PHILOS CONSTRUCT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: SCHLIEMANN, B. ET AL. (2012). COMPLEX FRACTURES OF THE PROXIMAL HUMERUS IN THE ELDERLY-OUTCOME AND COMPLICATIONS AFTER LOCKING PLATE FIXATION. MUSCULOSKELET SURG SUPPL 1, 96, S3-S11. THE AUTHORS CONDUCTED A RETROSPECTIVE STUDY TO EVALUATE FUNCTIONAL AND RADIOLOGICAL OUTCOMES AND PATIENT SATISFACTION AFTER LOCKING PLATE FIXATION OF THREE AND FOUR PART PROXIMAL HUMERUS FRACTURES WITH SYNTHES DEVICE, PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) PLATE. BETWEEN JANUARY 2004 AND DECEMBER 2008, 48 PATIENTS OLDER THAN 65 YEARS WERE TREATED; AVERAGE FOLLOW-UP WAS 44 MONTHS. OF 48 PATIENTS, 27 WERE SUBSEQUENTLY AVAILABLE FOR FOLLOW-UP. MEAN PATIENT AGE WAS 71 YEARS (RANGE: 65-85 YEARS); SEVEN PATIENTS WERE MEN AND 20 PATIENTS WERE WOMEN. PERCENTAGE INCIDENCES OF COMPLICATIONS WERE AS FOLLOWS: SCREW PERFORATION (22.2) ASSOCIATED WITH LOSS OF REDUCTION (44.4), IMPINGEMENT (18.5), IMPLANT FAILURE (3.7), AVASCULAR NECROSIS (29.6) AND PSEUDARTHROSIS (3.7). REVISIONS WERE REPORTED FOR SCREW PERFORATION (TWO), IMPINGEMENT (THREE), IMPLANT FAILURE (ONE), AVASCULAR NECROSIS (ONE) AND PSEUDARTHROSIS (ONE). THE AUTHORS NOTED THAT COMPLICATIONS MAY HAVE OCCURRED IN THE SAME PATIENT. THE AUTHORS CONCLUDED THAT, DESPITE A HIGH COMPLICATION RATE, THE RESULTS OF THE LOCKING PLATE FIXATION OF COMPLEX DISPLACED PROXIMAL HUMERUS FRACTURES IN THE ELDERLY ARE SATISFYING AND COMPARABLE TO THOSE OF PRIMARY ARTHROPLASTY AND MINIMALLY INVASIVE TREATMENTS. THIS IS A REPORTABLE MALFUNCTION REPORT. PERCENTAGE INCIDENCES OF COMPLICATIONS WERE REPORTED AS: IMPLANT FAILURE (3.7) AND IMPINGEMENT (18.5). THE AUTHORS NOTED THAT COMPLICATIONS MAY HAVE OCCURRED IN THE SAME PATIENT. THIS REPORT IS FOR AN UNKNOWN PHILOS CONSTRUCT. THIS REPORT IS 3 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278337 PLATE, FIXATION, BONE HRS DEPUY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1