BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5

    MDR report key: 6498865 · Received April 17, 2017

    Report

    Report Number
    0002249697-2017-01272
    Event Type
    Injury
    Date Received
    April 17, 2017
    Date of Event
    March 21, 2017
    Report Date
    May 25, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALTR INVOLVING AN UNKNOWN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. -DEVICE HISTORY REVIEW: NOT PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. -COMPLAINT HISTORY REVIEW: NOT PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR COULD THE ROOT CAUSE BE DETERMINED BECAUSE THE INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PATIENT HISTORY, HISTOPATHOLOGY REPORT & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING AND ELEVATED ION LEVEL INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL, DIMENSIONAL, FUNCTIONAL INSPECTION, AND MATERIAL ANALYSIS WERE NOT PERFORMED AS THE ITEM WAS NOT RETURNED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿THERE IS NO EXAMINATION OF THE EXPLANTED COMPONENTS, NO SURGICAL PATHOLOGIC REPORT FROM THE REVISION TISSUE, NO MARS MRI OR MRI FINDINGS CONSISTENT WITH ALTR, AND NO SERIAL PATHOLOGIC SERUM COBALT OR CHROMIUM LEVELS AVAILABLE. INTRAOPERATIVE HIP FLUID COBALT AND CHROMIUM LEVELS ARE OF NO CLINICAL SIGNIFICANCE AND HAVE NO BASELINE LEVELS. MILD TRUNNIONOSIS AS DESCRIBED AFTER EIGHT YEARS' IN SITU, DOES NOT REPRESENT PATHOLOGY WITHOUT SURGICAL HISTOPATHOLOGIC CONFIRMATION. FAILURE OF BIOLOGIC FIXATION IN A PATIENT ON CHRONIC STEROID THERAPY, GOUT AND LATER RADIATION THERAPY IS NOT UNEXPECTED. THERE IS NO EVIDENCE THIS CLINICAL SITUATION IS DUE TO FACTORS OF COMPONENT DESIGN, MANUFACTURING OR MATERIALS. CORTICAL HYPERTROPHY AT THE DISTAL STEM, RATHER THAN AT THE JUNCTION OF THE PROXIMAL AND MID-THIRD STEM, IS CONSISTENT WITH FAILURE OF BIOLOGIC FIXATION OF THE PROXIMAL STEM AND HAS NO POSSIBLE RELATIONSHIP TO "POTENTIAL TRUNNIONOSIS".¿ PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE REPORTED EVENT OF LOOSENING OF THE ACCOLADE STEM WAS CONFIRMED. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿FAILURE OF BIOLOGIC FIXATION IN A PATIENT ON CHRONIC STEROID THERAPY, GOUT AND LATER RADIATION THERAPY IS NOT UNEXPECTED. THERE IS NO EVIDENCE THIS CLINICAL SITUATION IS DUE TO FACTORS OF COMPONENT DESIGN, MANUFACTURING OR MATERIALS. CORTICAL HYPERTROPHY AT THE DISTAL STEM, RATHER THAN AT THE JUNCTION OF THE PROXIMAL AND MID-THIRD STEM, IS CONSISTENT WITH FAILURE OF BIOLOGIC FIXATION OF THE PROXIMAL STEM AND HAS NO POSSIBLE RELATIONSHIP TO "POTENTIAL TRUNNIONOSIS".

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ATTORNEY REPORTED CLIENT WHOM RECENTLY UNDERWENT REVISION SURGERY RELATIVE TO A STRYKER ACCOLADE TMZF, WHOM HAS EXPERIENCED POISONING SUBSEQUENT TO THE SURGERY AS WELL AS PROSTATE CANCER (WITH NO FAMILY HISTORY THEREOF).

    Description of Event or Problem · 1

    ATTORNEY REPORTED CLIENT WHOM RECENTLY UNDERWENT REVISION SURGERY RELATIVE TO A STRYKER ACCOLADE TMZF, WHOM HAS EXPERIENCED POISONING SUBSEQUENT TO THE SURGERY AS WELL AS PROSTATE CANCER (WITH NO FAMILY HISTORY THEREOF). UPDATED PER MEDICAL REVIEW: ON (B)(6) 2017 A RIGHT REVISION TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR A DIAGNOSIS OF "RIGHT HIP LOOSE FEMORAL COMPONENT WITH MILD TRUNNIONOSIS". "THE OPERATIVE REPORT NOTES, "EVIDENCE OF ELEVATED METAL IONS ... INDICATIVE OF POTENTIAL BEARING SURFACE ISSUES ... TRUNNIONOSIS ... MRI SOME EFFUSION ... NO SOFT TISSUE DESTRUCTION ... ELECT TO PROCEED WITH REVISION ..."

    Description of Event or Problem · 1

    ATTORNEY REPORTED CLIENT WHOM RECENTLY UNDERWENT REVISION SURGERY RELATIVE TO A STRYKER ACCOLADE TMZF, WHOM HAS EXPERIENCED POISONING SUBSEQUENT TO THE SURGERY AS WELL AS PROSTATE CANCER (WITH NO FAMILY HISTORY THEREOF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280386 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 21133701

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other