BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PKR INSERT X3 #2 RM/LL -8MM

    MDR report key: 3941255 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02775
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HRY
    PMA / PMN Number
    K082567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION SHOWED THE DEVICE TO BE UNREMARKABLE. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS INSUFFICIENT PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. 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 AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ADDITIONAL PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. CAT. NO.: (B)(4), TRIATHLON PKR FEMUR #2 RM/LL, LOT CODE: DPGA; CAT. NO.: (B)(4), TRIATHLON PKR BASEPLATE #2 RM/LL, LOT CODE: GXAV. AN EVENT REGARDING PAIN INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL INSPECTION SHOWED THE DEVICE TO BE UNREMARKABLE. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS INSUFFICIENT PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. 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 AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION DUE TO PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION DUE TO PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419131 TRIATHLON PKR INSERT X3 #2 RM/LL -8MM KNEE JOINT FEMOROTIBIAL METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS. HRY STRYKER ORTHOPAEDICS-MAHWAH MKPPWP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention