BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMHS CP ROUND IMPLAN

    MDR report key: 2000408 · Received February 24, 2011

    Report

    Report Number
    8010764-2011-00006
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    December 3, 2010
    Report Date
    February 24, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS GERMANY
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE ANALYSIS CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE PROXIMAL PORTION OF THE IMHS CP NAIL FRACTURED BY THE INITIATION AND SUBSEQUENT PROPAGATION OF FATIGUE CRACKING. THE FATIGUE CRACKING EVENTUALLY PROPAGATED TO AN EXTENT THAT THE REMAINING CROSS-SECTIONAL AREA OF THE NAIL COULD NOT BEAR THE IMPOSED PATIENT LOADING, WHICH LEAD TO AN OVERLOAD FRACTURE. FATIGUE CRACKING IS CAUSED BY THE NAIL BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. THESE EXCESSIVE CYCLIC STRESSES MAY BE CAUSED BY ANY NUMBER OF CONDITIONS, INCLUDING BUT NOT LIMITED TO (1) EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION, (2) APPLICATIONS OF LOADS IN EXCESS OF THE MATERIAL'S STRENGTH, AND/OR (3) POOR BONE QUALITY. THERE WAS ALSO A FRACTURE NOTED AT THE DISTAL SLOT OF THE IMHS CP NAIL. SINCE THE FRACTURE DID NOT PROPAGATE THROUGH THE ENTIRE CROSS-SECTION OF THE DISTAL PORTION OF THE NAIL, NO ANALYSIS OF THE DISTAL FRACTURE SURFACE WAS POSSIBLE. NO MATERIAL OR MANUFACTURING DEVIATIONS WERE FOUND DURING THIS INVESTIGATION.

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED DUE TO BREAKAGE OF THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMHS CP ROUND IMPLAN IMHS CP 130 D 10 X 19.5L JDS SMITH & NEPHEW ORTHOPAEDICS GERMANY 71683010L 09LT37277

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R (B)(4), LOT # UNKNOWN