BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEDICACE. V40(TM) FEMORAL STEM

    MDR report key: 6118290 · Received November 21, 2016

    Report

    Report Number
    0002249697-2016-03713
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 19, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE PACKAGING OF A DEDICATE STEM WAS REPORTED. THE EVENT WAS CONFIRMED FOLLOWING INSPECTION OF RETURNED PART. DEVICE EVALUATION AND RESULTS: THE STEM WAS RETURNED INTACT IN ITS PACKAGING. IT WAS NOTED HOWEVER THAT THE PLASTIC PROTECTOR PACKAGING WAS DAMAGED AND FRACTURED INTO A NUMBER OF SEPARATE PIECES. NO DAMAGE TO THE STEM WAS NOTED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF MEDICAL RECORDS WAS NOT PERFORMED AS NONE WERE PROVIDED. NO FURTHER INFORMATION WAS REQUESTED AS THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO PATIENT FACTORS. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT. CONCLUSIONS: A INVESTIGATION CARRIED OUT BY THE SUPPLIER CONCLUDED " NO ACTION IS REQUIRED AT THIS TIME AS THERE WAS NO INDICATION OF A MANUFACTURING ISSUE. LMO QA PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS". THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE RISK MANAGER, RELATED THAT "THE LABEL WAS HARD TO REMOVE. WE WANTED TO OPEN IT TO TAKE THE IMPLANT IN THE 2ND PACKAGE. THE IMPLANT FELL ON THE FLOOR, IT IS NOT BROKEN, BUT THE PROTECTION RING BROKE. IT IS IMPOSSIBLE TO USE THE DIRECTION ELEMENT. WE USED ANOTHER IMPLANT REF 4900-1-133."

    Description of Event or Problem · 1

    THE RISK MANAGER, RELATED THAT "THE LABEL WAS HARD TO REMOVE. WE WANTED TO OPEN IT TO TAKE THE IMPLANT IN THE 2ND PACKAGE. THE IMPLANT FELL ON THE FLOOR, IT IS NOT BROKEN, BUT THE PROTECTION RING BROKE. IT IS IMPOSSIBLE TO USE THE DIRECTION ELEMENT. WE USED ANOTHER IMPLANT REF 4900-1-133"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770290 DEDICACE. V40(TM) FEMORAL STEM HIP IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH G5674598

    Patients

    Seq Age Sex Outcome Treatment
    1 Other