BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 4123219 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03628
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    May 7, 2014
    Report Date
    September 2, 2014
    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

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON PS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT AND STERILE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE REPORTED DEVICE, 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON PS FEM COMPONENT, CEMENTED; CAT# 5515-F-301; LOT# IWTRD; TRI TS BASEPLATE SIZE 4; CAT# 5521-B-400; LOT# JHBKD; TRIATHLON SYM PATELLA S33X9MM; CAT# 5550-L-339; LOT# LDJ895; TRI LM/RL TIB AUG SZ4 5MM; CAT# 5545-A-401; LOT# ER8CE6A; IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. 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 THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT UNDERWENT LINER EXCHANGE (B)(6) 2014 FOLLOWING REVISION FOR INFECTION WHICH OCCURRED ON (B)(6) 2013. ALL OTHER COMPONENTS RETAINED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT LINER EXCHANGE (B)(6) 2014 FOLLOWING REVISION FOR INFECTION WHICH OCCURRED ON (B)(6) 2013. ALL OTHER COMPONENTS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602941 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MMMP5L

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention