BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-LOC

    MDR report key: 1790197 · Received August 10, 2010

    Report

    Report Number
    1020279-2010-00223
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 8, 2010
    Report Date
    August 10, 2010
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE ANALYSES CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE 4.5MM LATERAL PROXIMAL TIBIA LOCKING PLATE FRACTURED BY METAL FATIGUE CRACKING. THE FATIGUE CRACKING EVENTUALLY PROPAGATED TO AN EXTENT THAT THE REMAINING CROSS-SECTIONAL AREA OF THE PLATE COULD NOT BEAR THE IMPOSED PATIENT LOADING, LEADING TO OVERLOAD FRACTURE. FATIGUE CRACKING IS CAUSED BY THE PLATE 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 EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION. NO MATERIALS OR MANUFACTURING DEVIATIONS WERE FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS TIBIAL LOOSENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE FRACTURED REQUIRING A REVISION SURGERY TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-LOC PLATE HRS SMITH & NEPHEW, INC. 09GM03463

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R