BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 3.5

    MDR report key: 4309872 · Received December 9, 2014

    Report

    Report Number
    0002249697-2014-04568
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS 180 CENTIMETERS IN HEIGHT. AN EVENT REGARDING WEAR INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED BASED ON THE AVAILABLE INFORMATION AND CONCLUDED: "WITH MANY RELEVANT POTENTIAL SOURCES OF INFORMATION NOT AVAILABLE, NO CERTAIN ROOT CAUSE OF FAILURE CAN BE ESTABLISHED FOR THIS CASE DUE TO LACK OF PROPER INFORMATION." 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, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    TRUNNIONS BETWEEN THE HEAD AND NECK. REVISION OF HEAD REQUIRED. SURGEON STATED PT HAD NO PAIN FOR 12 MONTHS POST PRIMARY IMPLANT THEN INCREASING JOINT PAIN FROM 12 MONTHS ONWARD.

    Description of Event or Problem · 1

    TRUNNIONOSIS BETWEEN THE HEAD AND NECK. REVISION OF HEAD REQUIRED. SURGEON STATED PT HAD NO PAIN FOR 12 MONTHS POST PRIMARY IMPLANT THEN INCREASING JOINT PAIN FROM 12 MONTHS ONWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795423 ACCOLADE 132 SIZE 3.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 40143502

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention