BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR FEM COMP #5 R-CEM

    MDR report key: 3970174 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02952
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    January 1, 2011
    Report Date
    July 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    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

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN TRIATHLON KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PERIPROSTHETIC FRACTURE FOLLOWING A FALL INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. CONCLUSION: IT IS REPORTED THAT THE PATIENT EXPERIENCED A FALL AND SUFFERED A PERIPROSTHETIC FRACTURE. MEDICAL REVIEW ON THE INFORMATION PROVIDED CONFIRMS THE PERIPROSTHETIC FRACTURE AND INDICATES THAT THE REPORTED DEVICES APPEAR TO REMAIN WELL FIXED. THE REPORTED DEVICES REMAIN IMPLANTED. IN THIS OSTEOPOROTIC PATIENT WITH A POST-TRAUMATIC FRACTURE OF THE DISTAL FEMUR THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC COMPONENT DESIGN, MANUFACTURING OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. BASED ON THE INFORMATION PROVIDED THERE IS NO EVIDENCE OR ALLEGATION THAT THE REPORTED FEMORAL COMPONENT CONTRIBUTED THE REPORTED PERIPROSTHETIC FRACTURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT WHILST COLLECTING RADIOLOGICAL DATA IT HAS COME TO LIGHT THAT A STUDY PARTICIPANT FELL AND SUSTAINED A PERI-PROSTHETIC FRACTURE, REQUIRING HOSPITALISATION AND SURGICAL INTERVENTION. THE CUSTOMER WILL PROVIDE FURTHER INFORMATION REGARDING THE EVENT ON RECEIPT OF MEDICAL RECORDS. THE CUSTOMER HAS INDICATED THAT THE ETHICS COMMITTEE, SPONSOR, MANUFACTURER AND R&I DEPARTMENTS WILL ALL BE INFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA EMAIL THAT THERE HAS BEEN AN ALLEGED SERIOUS ADVERSE EVENT IN THE STUDY ENTITLED THE (B)(4), WHICH IS BEING RUN AT (B)(4) AND HAS (B)(4) APPROVAL. THE STUDY IS FOLLOWING THE OUTCOMES OF PATIENTS WHO HAVE A TRIATHLON KNEE REPLACEMENT. THIS REPORT IS BEING PROVIDED RETROSPECTIVELY AS THE EVENT OCCURRED IN 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448373 TRIATHLON CR FEM COMP #5 R-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH SBYFC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention