BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 2232487 · Received August 25, 2011

    Report

    Report Number
    2249697-2011-01254
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    December 31, 2009
    Report Date
    August 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON PS FEM COMPONENT, CEMENTED; CAT# 5515-F-402, LOT# XEFU, TRIATHLON PRIM TIB BASEPLATE - CEMENTED; CAT# 5520-B-300, LOT# ZBPW, TRIATHLON SYMMETRIC X3 PATELLA; CAT# 5550-G-319, LOT# 855A, TRIATHLON FEMORAL PEG MODULAR DISTAL FIXATION; 5575-X-000, LOT# LBDDH, SIMPLEX P FULL DOSE 1 PAC; CAT# 6191-1001, LOT# RKP221. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INSTABILITY. AN EVALUATION OF THE DEVICES CANNOT BE PERFORMED AS THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT WAS REVISED DUE TO INSTABILITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 0NNMHE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention