BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE 132 SIZE 3.5

    MDR report key: 3843131 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-01980
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT UPDATED. AN EVENT REGARDING SEATING HEIGHT DISCREPANCY BETWEEN AN ACCOLADE TMZF STEM AND BROACH WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS WERE RETURNED. THE PROVIDED RECORDS WERE REJECTED FOR REVIEW BY A CONSULTING CLINICIAN. A DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. A COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED SEATING HEIGHT DISCREPANCY DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BROACH WAS 3 1/2 MM, IT WAS SET RIGHT WHERE THE DOCTOR WANTED IT. WHEN THE DOCTOR WENT TO PLACE THE REAL IMPLANT, IT SET AT 5 MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BROACH WAS 3 1/2 MM, IT WAS SET RIGHT WHERE THE DOCTOR WANTED IT. WHEN THE DOCTOR WENT TO PLACE THE REAL IMPLANT, IT SET AT 5 MM. AS PER THE SALES REP VIA A PHONE CALL: THE SURGEON PLACED THE BROACH AND IT SAT FLUSH. WHEN THE STEM WAS PLACED, IT SAT PROUD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321857 ACCOLADE 132 SIZE 3.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 43705904

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other