BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL LATERAL FEMUR PLATE AXSOS FOR RIGHT FEMUR 12 HOLE, L274MM

    MDR report key: 3092527 · Received May 3, 2013

    Report

    Report Number
    0008031020-2013-00129
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K050512
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE PLATE BROKE COULD BE CONFIRMED SINCE THE RETURNED DEVICE MATCHES THE REPORTED FAILURE. THE AXSOS PLATE IS FRACTURED IN THE NINTH SHAFT HOLE. THE SURFACE OF THE WHOLE PLATE SHOWS SEVERAL SCRATCHES AND DEFORMATIONS MOST PROBABLY CAUSED DURING IMPLANTATION AND/OR EXPLANTATION. PLEASE NOTE THAT SOME SURFACE DAMAGES LIKE CRACKS MADE DURING IMPLANTATION MAY LEAD TO A BREAKAGE OF THE DEVICE DURING HEALING PERIOD. WITH A DETAILED VIEW ON THE FRACTURE SURFACES OF THE FRAGMENTS SECONDARY WEAR SIGNS ARE VISIBLE. THE VISUAL EXAMINATION SHOWS A TYPICAL FATIGUE BREAKAGE SITE. X-RAYS WERE PROVIDED TO THE CLINICAL EXPERT, HE STATED: THE POOR RESOLUTION OF THE SUBMITTED X-RAYS AND THE MISSING CLINICAL DATA ALLOW ONLY FOR A LIMITED STATEMENT. THE X-RAYS (UNDATED) SHOW AN EXTENDED UNSTABLE DISTAL FEMUR FRACTURE WHICH HAS BEEN REDUCED AND FIXED WITH A LONG LATERAL AXSOS DISTAL FEMUR PLATE AND 3 CERCLAGES. THE PROXIMAL CERCLAGE AND THE PROXIMAL FOUR SCREWS ARE PLACED AROUND A PREVIOUS INSERTED GAMMA NAIL. THE INITIAL ORIF SHOWS A PERFECT FRAGMENT REDUCTION AND CORRECT POSITIONING OF THE HARDWARE. AFTER TWO MONTHS THE AXSOS PLATE IS BROKEN IN THE AREA OF THE FRACTURE SITE SHOWING AN ATROPHIC (POSSIBLY NECROTIC) BONE SEGMENT BETWEEN THE TWO DISTAL CERCLAGES. SIGNIFICANT FRAGMENT DISPLACEMENT. THE EARLY IMPLANT BREAKAGE HAS BEEN ASSUMEDLY CAUSED BY LONG TERM OVERLOADING PRIOR TO BONE CONSOLIDATION IN A COMPLETELY UNSTABLE FRAGMENT CONSTELLATION WITH INSUFFICIENT BONE-TO-BONE CONTACT. THERE IS ONLY SLIGHT CALLUS FORMATION INDICATING A DELAYED UNION. BASED ON THE INVESTIGATION RESULTS, THIS CASE COULD BE CLASSIFIED AS USER RELATED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SALES REP. REPORTED THAT THE CUSTOMER HAS EXPLANTED AN AXSOS PLATE WHICH IS BROKEN. THE PLATE WAS IMPLANTED APPROX. 2 MONTHS BEFORE.

    Description of Event or Problem · 1

    THE SALES REP. REPORTED THAT THE CUSTOMER HAS EXPLANTED AN AXSOS PLATE WHICH IS BROKEN. THE PLATE WAS IMPLANTED APPROX 2 MONTHS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194698 DISTAL LATERAL FEMUR PLATE AXSOS FOR RIGHT FEMUR 12 HOLE, L274MM IMPLANT HRS STRYKER OSTEOSYNTHESIS-SELZACH M20322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention