BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE NAIL GOLD 10X38 RETRO/TIB

    MDR report key: 4252020 · Received November 14, 2014

    Report

    Report Number
    1020279-2014-00695
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 23, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICES WERE RETURNED AND EVALUATED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES. THE AS-RECEIVED KNEE NAIL WAS EXAMINED VISUALLY, STEREOMICROSCOPICALLY, AND WITH A SCANNING ELECTRON MICROSCOPE (SEM). AN ELEMENTAL ANALYSIS WAS PERFORMED ON THE NAIL FRACTURE SURFACE USING ENERGY DISPERSIVE X-RAY ANALYSIS (EDXA) TECHNIQUE IN CONJUNCTION WITH THE SEM. MACROSCOPIC EXAMINATION OF THE AS-RECEIVED NAIL SHOWED A FRACTURE AT THE HOLE IN THE END THE NAIL. MICROSCOPIC EXAMINATION SHOWED BURNISHED AREAS, EQUIAXED DIMPLES (MICRO-VOID COALESCENCE, OR MVC), AND FATIGUE STRIATIONS. BURNISHING IS CAUSED BY TWO SURFACES RUBBING TOGETHER POST-FRACTURE. MVC IS INDICATIVE OF A DUCTILE OVERLOAD. BEACH MARKS ARE A MACROSCOPIC PHENOMENA COMMONLY ASSOCIATED WITH FATIGUE LOADING. THESE FEATURES ARE TYPICAL OF METAL FATIGUE CRACKING. FATIGUE CRACKING IS CAUSED BY THE IMPLANT BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. EDXA SPECTRA WERE COLLECTED FROM THE FRACTURE SURFACE OF THE NAIL TO DETERMINE THE COMPOSITION OF THE NAIL AND SHOWED NO ABNORMALITIES. FROM THE ANALYSES CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE KNEE 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, LEADING TO 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. NO MATERIALS OR MANUFACTURING DEVIATIONS WERE FOUND IN THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738223 KNEE NAIL GOLD 10X38 RETRO/TIB KNEE IMPLANT JWH SMITH & NEPHEW, INC. 07LM08354

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention