BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5

    MDR report key: 7513872 · Received May 15, 2018

    Report

    Report Number
    0002249697-2018-01437
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 18, 2018
    Report Date
    July 23, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING LOOSENING INVOLVING ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS SHOWS A RECENTLY EXPLANTED STEM AND HEAD WITH NOTHING REMARKABLE TO REPORT. FROM THE PHOTOGRAPHS PROVIDED THERE IS NO EVIDENCE OF DAMAGE TO THE DEVICES. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED: REVIEW OF THESE RECORDS CONFIRMS THE REVISION SURGERY OCCURRED, HOWEVER, REPORTED LOOSENING AND/OR THE ROOT CAUSE OF THE NEED FOR THIS REVISION CANNOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS AVAILABLE. FURTHER DOCUMENTATION REQUIRED FOR COMPLETION OF THIS ASSESSMENT WOULD INCLUDE: OPERATIVE REPORTS FROM THE INDEX AND REVISION SURGERIES, DATED SURGICAL IMPLANT RECORDS FROM THE SURGERIES. DATED PRE AND POST OP XRAYS/IMAGING FROM THE INDEX AND REVISION SURGERIES, OUTPATIENT OFFICE/CLINIC NOTES, IMPLANT RETRIEVAL, DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS FROM THE INDEX AND REVISION SURGERIES, DATED SURGICAL IMPLANT RECORDS FROM THE SURGERIES, DATED PRE AND POST OP XRAYS/IMAGING FROM THE INDEX AND REVISION SURGERIES, OUTPATIENT OFFICE/CLINIC NOTES AND IMPLANT RETRIEVAL ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    REVISION FOR ACCOLADE TMZF AS THERE WAS LOOSENING OF THE STEM. THEY THOUGHT THEY WERE GOING TO HAVE TO REPLACE LINER BUT DIDN¿T NEED TO.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Description of Event or Problem · 1

    REVISION FOR ACCOLADE TMZF AS THERE WAS LOOSENING OF THE STEM. THEY THOUGHT THEY WERE GOING TO HAVE TO REPLACE LINER BUT DIDN¿T NEED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357180 ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 24337602

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R