BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 3781151 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01710
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    September 7, 2012
    Report Date
    April 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A TRIATHLON BASEPLATE WAS REPORTED. THE EVENT WAS CONFIRMED. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT CONCLUDED: ¿THE COMPONENTS ARE NOTED NOT TO BE LOOSE AT REVISION SURGERY AND WERE REMOVED WITH OSTEOTOMES. THERE IS NO EVIDENCE OF COMPONENT MIGRATION ON SERIAL X-RAYS. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION.¿ DHR REVIEW WAS SATISFACTORY. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. THE REPORTED TIBIAL COMPONENT LOOSENING WAS NOT CONFIRMED AS IT WAS DISCOVERED DURING REVISION SURGERY THAT THE COMPONENT WAS FIXED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRIMARY SURGERY, PATIENT STILL HAD PAIN AND SWELLING IN RIGHT KNEE. PATIENT HAD A CORTISONE SHOT AND BONE SCAN SHOWED IMPLANT WAS LOOSE. PATIENT THEN HAD A REVISION AND IS FEELING BETTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRIMARY SURGERY, PATIENT STILL HAD PAIN AND SWELLING IN RIGHT KNEE. PATIENT HAD A CORTISONE SHOT AND BONE SCAN SHOWED IMPLANT WAS LOOSE. PATIENT THEN HAD A REVISION AND IS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260277 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH FXYVA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention