BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 3024036 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01139
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    January 1, 2010
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. NO MEDICAL RECORDS WERE MADE AVAILABLE FOR EVALUATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE REPORTED DEVICE, X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY, FOLLOW-UP NOTES AND PATHOLOGY REPORTS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL. THE REPORTED EVENT REGARDING INFECTION INVOLVING A TRIATHLON CR X3 TIBIAL INSERT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. DEVICES WERE RETAINED AT (B)(6). MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTERS INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROX 1.0 Y. THE POLYETHYLENE TIBIAL INSERT WAS REVISED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~1.0 Y. THE POLYETHYLENE TIBIAL INSERT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126357 TRIATHLON CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MNLMDD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention