BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS FEM COMPONENT, CEMENTED

    MDR report key: 2001646 · Received February 22, 2011

    Report

    Report Number
    2249697-2011-00202
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K042993
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICES CANNOT BE PERFORMED AS THE DEVICES WERE REQUESTED BY THE PATIENT AND NOT RETURNED TO THE MANUFACTURER. LOT CODE INFORMATION WAS REQUESTED. INFORMATION PROVIDED STATED THAT NO MEDICAL RECORDS OR X-RAYS ARE AVAILABLE. IF DEVICES OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE FOLLOWING OTHER DEVICES WERE LISTED IN THIS REPORT: TRIATHLON PRIM TIB BASEPLATE - CEMENTED: CAT# 5520-5-400, LOT UNKNOWN. TRIATHLON-PS TIBIAL INSERT #4-16MM: CAT# 5532-P-416, LOT UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INSTABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT REVISED BECAUSE OF INSTABILITY. PATIENT DONE ELSEWHERE. NO NOTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS FEM COMPONENT, CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention