BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR FEM COMP #7 R-CEM

    MDR report key: 3113398 · Received May 15, 2013

    Report

    Report Number
    0002249697-2013-01675
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    October 1, 2012
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS 71 INCHES IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED THAT THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, OR MATERIALS WERE RESPONSIBLE FOR THE SEQUELAE OF THIS POST-OPERATIVE TOTAL KNEE ARTHROPLASTY INFECTION. THE STERILIZATION SCIENCES DEPARTMENT CARRIED OUT A MICROBIOLOGICAL ASSESSMENT OF THE MEDICAL RECORDS PROVIDED AND INDICATED THAT BASED ON THE DATA REVIEWED, IT HAS BEEN DETERMINED THAT THE INTRODUCTION OF THE REPORTED CAUSATIVE AGENT OF THIS POST-OPERATION INFECTION WAS NOT VIA THE MEDICAL DEVICES. DEVICE HISTORY REVIEW: THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT OR STERILE LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED HOWEVER THERE IS NO EVIDENCE THAT PROSTHETIC RELATED FACTORS CAUSED REPORTED INFECTION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWELLING AND HIGH LEVELS OF FLUID. PATIENT ALSO HAD A STAPH INFECTION. PATIENT STATES THAT HE HAD PROBLEMS SINCE PRIMARY IMPLANT SURGERY. PATIENT HAD REVISION SURGERY ON HIS KNEE ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWELLING AND HIGH LEVELS OF FLUID. PATIENT ALSO HAD A STAPH INFECTION. PATIENT STATES THAT HE HAD PROBLEMS SINCE PRIMARY IMPLANT SURGERY. PATIENT HAD REVISION SURGERY ON HIS KNEE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214070 TRIATHLON CR FEM COMP #7 R-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH S8ASA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention