BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD CON DIST STEM 17 X 155 MM

    MDR report key: 4100077 · Received September 18, 2014

    Report

    Report Number
    0002249697-2014-03553
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K022549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOB UPDATED. AN EVENT REGARDING SUBSIDENCE INVOLVING A RESTORATION MODULAR STEM WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: "THERE IS NO EVIDENCE THIS CLINICAL SITUATION WAS THE RESULT OF FAULTY FEMORAL COMPONENT DESIGN, MANUFACTURING, OR MATERIALS." DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. A MEDICAL REVIEW WAS PERFORMED AND INDICATED THAT THERE WAS NO EVIDENCE OF A DEVICE RELATED ISSUE. NO ACTION IS REQUIRED 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 PATIENT IMPLANT SUBSIDED. SURGEON SUGGESTS THAT IT WAS UNDERSIZED. REPLACED WITH ANOTHER RESTORATION MODULAR STEM LARGER IN SIZE. THIS WAS ON RIGHT SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IMPLANT SUBSIDED. SURGEON SUGGESTS THAT IT WAS UNDERSIZED. REPLACED WITH ANOTHER RESTORATION MODULAR STEM LARGER IN SIZE. THIS WAS ON RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578544 MOD CON DIST STEM 17 X 155 MM IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH CAXN922C

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R