BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLAR ULNA

    MDR report key: 16237071 · Received January 24, 2023

    Report

    Report Number
    0002249697-2023-00066
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    October 27, 2022
    Report Date
    January 24, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING LOOSENING INVOLVING AN UNKNOWN SOLAR ULNA WAS REPORTED. THE EVENT WAS CONFIRMED VIA CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: THIS PATIENT UNDERWENT A PRIMARY SOLAR TOTAL ELBOW PROSTHESIS WHICH FAILED AND SUBSEQUENTLY UNDERWENT A REVISION ALSO WITH A SOLAR TOTAL ELBOW PROSTHESIS. THIS REVISION IMPLANT ALSO FAILED AND ANOTHER REVISION IS CONTEMPLATED. THE ROOT CAUSE OF FAILURE OF THIS SECOND REVISION IMPLANT CANNOT BE DETERMINED WITH CERTAINTY. NOR CAN THE CAUSE OF THE PRIMARY SURGERY AND THE FIRST REVISION SURGERY BE DETERMINED. THERE IS NOT ENOUGH INFORMATION PROVIDED. I CAN CONFIRM THAT THE IMPLANT PLACED IN 2015 HAS FAILED DUE TO LOOSENING, OSTEOLYSIS AND DISASSOCIATION FROM THE BONE. THE ROOT CAUSE OF THIS TYPE OF FAILURE IS MULTIFACTORIAL INCLUDING SURGICAL TECHNIQUE FACTORS, PATIENT FACTORS SUCH AS ACTIVITY LEVEL, BMI, AND HOST BONE INTEGRITY AND STRENGTH. AT THIS POINT IT DOES NOT APPEAR THAT ANY CAUSALITY OF THE FAILURE IS DUE TO THE IMPLANT ITSELF. GIVEN THE OBVIOUS RADIOLUCENCIES AND OSTEOLYSIS OF THE HUMERUS I BELIEVE IT WOULD WISE TO REPLACE IT RATHER THAN MATING IT WITH A NEW ULNAR COMPONENT. PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WILL BE REVISED DUE TO LOOSENING OF THE ULNA COMPONENT AND OSTEOLYSIS SURROUNDING THE HUMERAL COMPONENT. THE EVENT WAS CONFIRMED BY CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    A PATIENT SPECIFIC IMPLANT REQUEST FORM WAS RECEIVED FOR THE PATIENT'S RIGHT ELBOW. NOTED ON THE FORM : PRIMARY TOTAL ELBOW SURGERY PERFORMED PRE 2015 WITH NO IMPLANT RECORDS TO BE FOUND PATIENT WAS REVISED IN (B)(6) 2015. I WAS ABLE TO DIG UP THESE IMPLANT RECORDS. THE REVISED COMPONENT THAT WAS USED IN THE 2015 SURGERY WAS THE (B)(4) LOT MLN43A. DR. WANTS TO BUILD A CUSTOM ULNA IMPLANT THAT WILL MADE WITH THE CURRENT HUMERAL IMPLANT BUT ALSO HAVE THE OPTION OF USING THE MRS HUMERAL SIDED IMPLANT IF THE CURRENT HUMERAL IMPLANT CAN NOT BE SALVAGED SO IT WILL NEED TO MADE WITH THAT IMPLANT ALSO. CURRENT ULNA IMPLANT HAS ERODED THROUGH THE BONE CAUSE FAILURE AND LITTLE TO NO RANGE OF MOTION FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619705 UNKNOWN SOLAR ULNA PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED JDC STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Hospitalization| R