BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3676958 · Received March 13, 2014

    Report

    Report Number
    2520274-2014-10249
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Report Date
    February 16, 2014
    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

    EYRES, K., JOHNSTON, A., TOMS, A., AND TSIRIDIS, E. (2012). PERIPROSTHETIC FRACTURES IN THE DISTAL FEMUR FOLLOWING TOTAL KNEE REPLACEMENT: A REVIEW AND GUIDE TO MANAGEMENT. THE KNEE, 19, 156-162. THIS REPORT IS FOR AN UNKNOWN LESS INVASIVE STABILIZATION SYSTEM PLATE. 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: EYRES, K., JOHNSTON, A., TOMS, A., AND TSIRIDIS, E. (2012). PERIPROSTHETIC FRACTURES IN THE DISTAL FEMUR FOLLOWING TOTAL KNEE REPLACEMENT: A REVIEW AND GUIDE TO MANAGEMENT. THE KNEE, 19, 156-162. THE AUTHORS REVIEW CURRENT MANAGEMENT OF DISTAL FEMORAL PERIPROSTHETIC FRACTURES AROUND THE KNEE AND GIVE SUGGESTIONS TO THE BEST CURRENT AVAILABLE OPTIONS. THEY DISCUSS: THE RISK FACTORS TO THE OCCURRENCE OF PERIPROSTHETIC FRACTURES; PRE-OPERATIVE ASSESSMENT AND PLANNING OF FRACTURE MANAGEMENT; CLASSIFICATION SYSTEMS OF FRACTURES; MANAGEMENT OPTIONS; TREATMENT METHODS; RETROGRADE INTRAMEDULLARY NAILING; LOCKED PLATING WITH MENTION OF SYNTHES DEVICE, LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATING; REVISION ARTHROPLASTY; AND SPECIAL CIRCUMSTANCES. A COMPREHENSIVE SUMMARY OF CASE REPORTS ON THE MANAGEMENT OF SUPRACONDYLAR PERIPROSTHETIC FRACTURES FROM 2000 TO 2010 IS PRESENTED AS WELL AS A MANAGEMENT ALGORITHM. IT IS SUBSEQUENTLY REPORTED FROM THIS ARTICLE THAT SURGEONS NEED TO PLAN FOR THE UNANTICIPATED, HAVING CABLES, CEMENT, STRUT GRAFTS AND REVISION COMPONENTS ON HAND EVEN WHEN IT IS EXPECTED THAT PLATING OF NAILING WILL DO. THIS ARTICLE SUMMARIZES POSTOPERATIVE FINDINGS FROM OTHER PUBLISHED ARTICLES. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN LISS PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150069 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1