BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGEMENTAL ARTICULAR SURFACE

    MDR report key: 3820030 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00621
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE SURGICAL TECHNIQUE STATES NOT TO USE A HINGE POST FROM ANOTHER ARTICULAR SURFACE SIZE. IT IS UNKNOWN IF THE IMPLANTED ARTICULAR SURFACE AND HINGE POST EXTENSION COMBINATION CONTRIBUTED TO THE FRACTURE OF THE HINGE MECHANISM. FRACTURE OF THE HINGE POST MECHANISM MAY BE INFLUENCED BY MULTIPLE FACTORS, INCLUDING BUT NOT LIMITED TO, PATIENT ANATOMY, WEIGHT, AND RANGE OF MOTION. HYPEREXTENSION HAS BEEN FOUND TO BE RELATED TO PREVIOUS FRACTURES OF THE HINGE POST MECHANISM. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. VISUAL EXAMINATION OF THE HINGE MECHANISM CONFIRMS THE ANTERIOR PORTION OF THE THREADS HAS FRACTURED OFF. THE THREADING ON BOTH THE HINGE POST EXTENSION AND THE HINGE MECHANISM APPEARS TO HAVE BEEN STRIPPED. IT IS UNKNOWN IF THIS OCCURRED PRIOR TO OR AFTER THE FRACTURE. THE RETURNED ARTICULAR SURFACE IS A 17 MILLIMETER HEIGHT, WHILE THE RETURNED HINGE POST EXTENSION IS FROM A 12 MILLIMETER HEIGHT ROTATING HINGE KNEE ARTICULAR SURFACE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE HINGE POST EXTENSION THAT WAS IMPLANTED WITH THE SEGMENTAL ARTICULAR SURFACE IDENTIFIED NO DEVIATIONS OR ANOMALIES. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATIONS OF THE ARTICULAR SURFACES USED. A COMPLAINT SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR ARTICULAR SURFACES PACKAGED WITH THIS LOT OF HINGE POST EXTENSIONS. PRIMARY OPERATIVE NOTES INDICATE THAT THE PATIENT HAD A HISTORY OF INFECTION AND PREVIOUS DEBRIDEMENTS. THIS SURGERY WAS THE SECOND PHASE OF A TWO-STAGE REVISION DUE TO INFECTION. THE NOTES INDICATE THAT THE PATIENT HAD A LARGE TIBIAL DEFICIENCY AND HAD PREVIOUSLY LOST THE MCL. NO INDICATIONS REGARDING ARTICULAR SURFACE COMPONENT SELECTION OR TRIALING WERE STATED. OPERATIVE NOTES FROM THE REVISION SURGERY INDICATE THAT THE PATIENT HAD EXPERIENCED A 20 DEGREE HYPEREXTENSION. METALLOSIS WAS NOTED THROUGHOUT THE KNEE. THE HINGE POST EXTENSION WAS NOTED TO BE LOOSE BECAUSE THE HINGE POST HAD FRACTURED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO BREAKAGE OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288914 SEGEMENTAL ARTICULAR SURFACE KRO ZIMMER INC 60960545

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention