BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC MTP PLATE

    MDR report key: 4942969 · Received July 27, 2015

    Report

    Report Number
    1043534-2015-00046
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    April 1, 2015
    Report Date
    July 27, 2015
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    PMA / PMN Number
    K120359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PLATE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMS THAT THE PLATE HAS FRACTURED. ELEMENTAL ANALYSIS WAS CONDUCTED ON THE FRACTURE FACE AND THE TOPSIDE OF THE IMPLANT. THE SPECTRUM ACQUIRED FROM THE FRACTURE FACE SHOWED THE CONCENTRATION OF ALUMINUM TO BE BELOW THE MINIMUM LIMIT. THE SPECTRUM ACQUIRED FROM THE TOPSIDE OF THE IMPLANT SHOWED THE CONCENTRATION OF ALUMINUM TO BE ABOVE THE MAXIMUM LIMIT. . ALSO THE FRACTURE FEATURES WERE EVALUATED USING LOW POWER LIGHT MICROSCOPY AND SCANNING ELECTRON MICROSCOPY (SEM). THIS REVIEW FOUND THAT THE FRACTURE OCCURRED THROUGH THE TWO THREADED SCREW HOLES AT PROXIMAL END OF THE PLATE, LEAVING THREE FRACTURE FACES. THE FRACTURE INITIATION SITES COULD NOT BE IDENTIFIED DUE TO THE DEFORMATION OF THE FRACTURE FACES THAT OCCURRED AFTER THE PLATE FRACTURED. BUT FRACTURE FEATURES ON ONE OF THE FRACTURES SUGGESTED WHAT APPEARED TO BE AN AREA OF FRACTURE INITIATION. AT HIGHER MAGNIFICATIONS FATIGUE STRIATIONS WERE EVIDENT ACROSS THE FRACTURE FACE. THE FRACTURE APPEARED TO HAVE INITIATED ON THE TOPSIDE OF THE IMPLANT AND PROPAGATED THROUGH THE IMPLANT CROSS SECTION IN A FATIGUE MODE UNTIL COMPLETE SEPARATION OCCURRED. THERE ARE MANY CLINICAL FACTORS THAT CAN AFFECT THE RESULTS OF ANY SURGERY, SUCH AS PATIENT ACTIVITY, IMPLANT ALIGNMENT, AND SURGICAL TECHNIQUE. THEREFORE, WITH THE INFORMATION PROVIDED CONCLUSIONS RELATED TO PRODUCT USE OR CONTRIBUTION CANNOT BE MADE.

    Description of Event or Problem · 1

    ALLEGEDLY, A BROKEN PLATE HAD TO BE REVISED. THE PATIENT MTPJ HAD NOT FUSED. THIS PROBABLY LED TO THE EXCESS FORCE ON THE PLATE AND LED TO THE BREAK. SURGEON ACKNOWLEDGES PLATE POSITION WAS NOT OPTIMAL AT IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486638 ORTHOLOC MTP PLATE SMALL JOINT COMPONENT HRS WRIGHT MEDICAL TECHNOLOGY, INC. 1537065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention