BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR FEM COMP #5 R-CEM

    MDR report key: 3381147 · Received October 2, 2013

    Report

    Report Number
    0002249697-2013-03177
    Event Type
    Injury
    Date Received
    October 2, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PATIENT TRAUMA LEADING TO A FRACTURED HIP INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE PATIENT INVOLVED IS PART-TAKING IN A (B)(4) STUDY FOR THE TRIATHLON KNEE. THE PATIENT REPORTEDLY FELL AND SUFFERED A FRACTURED HIP. THE TRIATHLON COMPONENTS REMAIN IMPLANTED AND APPEAR TO BE UNAFFECTED BY THE PATIENT'S FALL. BASED ON THE PROVIDED INFORMATION, THE TRIATHLON KNEE COMPONENT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CLINICAL SCIENTIST FROM (B)(6) HOSPITAL REPORTED AN ALLEGED ADVERSE EVENT IN A (B)(4)STUDY (ETHICS REF (B)(4)) THAT IS BEING RUN AT NBT. THE CUSTOMER REPORTED THAT A STUDY PARTICIPANT HAD ALLEGEDLY FALLEN AT THEIR HOME AND SUSTAINED A FRACTURED HIP AND LOWER FEMUR. THE CUSTOMER REPORTS THAT SURGERY IS REQUIRED TO MANAGE THE FRACTURES. THE CUSTOMER REPORTS THAT THE PATIENT ORIGINALLY HAD A RIGHT TRIATHLON KNEE REPLACEMENT IN (B)(6) 2007. THE CUSTOMER REPORTS THAT MEDICAL DOCUMENTATION WILL BE FORWARDED ONCE ACCESSED.

    Description of Event or Problem · 1

    CLINICAL SCIENTIST FROM (B)(6) REPORTED AN ALLEGED ADVERSE EVENT IN A STUDY ENTITLED (B)(6). THE CUSTOMER REPORTED THAT A STUDY PARTICIPANT HAD ALLEGEDLY FALLEN AT THEIR HOME AND SUSTAINED A FRACTURED HIP AND LOWER FEMUR. THE CUSTOMER REPORTS THAT SURGERY IS REQUIRED TO MANAGE THE FRACTURES. THE CUSTOMER REPORTS THAT THE PATIENT ORIGINALLY HAD A RIGHT TRIATHLON KNEE REPLACEMENT IN (B)(6) 2007. THE CUSTOMER REPORTS THAT MEDICAL DOCUMENTATION WILL BE FORWARDED ONCE ACCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496972 TRIATHLON CR FEM COMP #5 R-CEM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH SDDFD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R