BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4263829 · Received November 20, 2014

    Report

    Report Number
    0002249697-2014-04333
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CAUSES FOR THIS REVISION ARE UNKNOWN. THE FOLLOWING ADDITIONAL DEVICE WAS LISTED IN THIS REPORT: CAT 6260-9-240 V40 COCR LFIT HEAD 40MM/+4 LOT CODE MHHN11. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE WAS UNREMARKABLE. A REVIEW OF THE DEVICE IMAGES BY A CLINICAL CONSULTANT INDICATED "THIS ACCOLADE STEM WAS LOOSE, IT HAS NO BONY INGROWTH WHATSOEVER VISIBLE ANYWHERE ON THE SURFACE. THERE IS SOME COLOR STAINING ON THE HA-COATING DUE TO PROTEIN ABSORPTION WHICH IS NORMAL FOR EITHER A LOOSE STEM OR A VERY SHORT IMPLANTATION INTERVAL BEFORE OSSEOINTEGRATION OCCURS. ALSO THE SLIGHT POLISHING VISIBLE AROUND THE STEM TIP IS SUGGESTIVE FOR A LOOSE STEM DURING SOME TIME AND SUGGESTS THIS STEM WAS IN PLACE FOR MORE THAN A FEW WEEKS. THERE ARE ALSO SOME LOCAL STAINS ALONG THE MEDIAL SECTION OF THE UNCOATED DISTAL STEM THAT ARE MORE DIFFICULT TO ¿READ¿ WITHOUT ADDITIONAL INVESTIGATION" A DIMENSIONAL INSPECTION CONFIRMED THAT THE RETURNED STEM CONFORMED TO THE REQUIRED PROFILES OUTLINED AS PER OPERATION SEQUENCE 26-28 OUTLINED IN IGS-0030930, VER. 2. A REVIEW OF THE DHR ALSO DID NOT INDICATE ANY EVIDENCE OF A DIMENSIONAL ISSUE. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED HOWEVER A REVIEW OF THE DEVICES IMAGES BY A CLINICAL CONSULTANT INDICTED THAT THE STEM WAS LOOSE. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES AND X-RAYS 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 · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP DUE TO UNKNOWN REASON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754039 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 28447901

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention