BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PKR INSERT X3 #1 RM/LL -8MM

    MDR report key: 3875339 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02318
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    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 IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN LINER. ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 5610-F-202 TRI PKR FEMUR#2 RM/LL LOT CODE UNKNOWN. CAT 5620-B-102 TRI PKR BASEPLATE #1 RM/LL LOT CODE WDA1A. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. THE EVENT DESCRIPTION INDICATED THE BASEPLATE WAS LOOSE. NO ADDITIONAL ALLEGATIONS WERE REPORTED AGAINST THE REMAINING DEVICES. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. THE EVENT DESCRIPTION INDICATED THE BASEPLATE WAS LOOSE. NO ADDITIONAL ALLEGATIONS WERE REPORTED AGAINST THE REMAINING DEVICES. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN WHICH RESULTED IN KNEE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN WHICH RESULTED IN KNEE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN WHICH RESULTED IN KNEE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352990 TRIATHLON PKR INSERT X3 #1 RM/LL -8MM KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P NPJ STRYKER ORTHOPAEDICS-MAHWAH MLNE57

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention