BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5547674 · Received April 5, 2016

    Report

    Report Number
    0002249697-2016-01090
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    March 11, 2016
    Report Date
    March 11, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. AN EVENT REGARDING REVISION SURGERY INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT 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. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2007, AN ACCOLADE WAS IMPLANTED INTO THE PATIENT'S LEFT HIP. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6) 2013, THE ACCOLADE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER HIP PROSTHESIS. IT IS ALSO ALLEGED THAT ON OR ABOUT (B)(6) 2013, THE SURGEON REMOVED THE PROSTHESIS FOR THE REVISION SURGERY AND REPLACED IT WITH ANOTHER PROSTHESIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2007, AN ACCOLADE WAS IMPLANTED INTO THE PATIENT'S LEFT HIP. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6) 2013, THE ACCOLADE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER HIP PROSTHESIS. IT IS ALSO ALLEGED THAT ON OR ABOUT (B)(6) 2013, THE SURGEON REMOVED THE PROSTHESIS FOR THE REVISION SURGERY AND REPLACED IT WITH ANOTHER PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203708 ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 18347601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R