BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS FEM COMPONENT, CEMENTED

    MDR report key: 3119015 · Received May 19, 2013

    Report

    Report Number
    0002249697-2013-01696
    Event Type
    Injury
    Date Received
    May 19, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K042993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY AND PAIN INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION INDICATED THE TRIATHLON PS FEMORAL COMPONENT HAS BONE CEMENT IN AREAS OUTSIDE OF THE CEMENT POCKETS, THIS EXCESS CEMENT SHOULD HAVE BEEN CLEANED PRIOR TO IMPLANTATION. THERE IS EVIDENCE OF BONE INTERDIGITATION PRESENT. THE COMPONENT APPEARS NORMAL FOR A COMPONENT THAT WAS IN VIVO AND SUBSEQUENTLY EXPLANTED. FURTHER INSPECTION WAS NOT PERFORMED. THE MEDICAL NOTES PROVIDED RELATE TO PRE-REVISION MEDICAL ASSESSMENTS AND THE X-RAYS PROVIDED ARE EXCEPTIONALLY POOR QUALITY, THEREFORE MEDICAL REVIEW IS NOT POSSIBLE WITH THE INFORMATION PROVIDED. THERE HAVE BEEN NO REPORTED DISCREPANCIES OR EVENTS FOR THE REFERENCED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS FURTHER INFORMATION IS NEEDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN #6 TRIATHALON FEMUR. ALSO LISTED IN THIS REPORT IS UNKNOWN BASEPLATE, UNKNOWN POY INSERT AND UNKNOWN PATELLA. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR CONTINUED PAIN FROM PRIMARY TKA. REPLACEMENTS WERE TRIATHALON TS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR CONTINUED PAIN FROM PRIMARY TKA. REPLACEMENTS WERE TRIATHALON TS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220675 TRIATHLON PS FEM COMPONENT, CEMENTED IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH FABY

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization