BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11704591 · Received April 21, 2021

    Report

    Report Number
    0002249697-2021-00715
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 21, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HRY
    UDI-DI
    07613327015904
    PMA / PMN Number
    K071881
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON PKR FEMUR #1 RM/LL; 5610-F-102 ; EYE9T. TRIATHLON PKR BASEPLATE #2 RM/LL; 5620-B-202 ; EYE9AA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REPORTED EVENT AN EVENT REGARDING PAIN INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE 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 DEVICE, PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    AS REPORTED: "PT. PRESENTED WITH PAIN REQUIRING REVISION OF A RPKR. SURGEON REMOVED THE PKR AND IMPLANTED TRIATHLON/TRIATHLON-TS COMPONENTS. NO COMPLAINTS HAVE BEEN FILED AGAINST THE PKR COMPONENTS." SPOKE TO THE REP, WHO PROVIDED PRIMARY AND REVISION USAGE SHEETS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596176 TRIATHLON PKR INSERT X3 #2 RM/LL -8MM PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY STRYKER ORTHOPAEDICS-MAHWAH 5630-G-228 XT8YKN 07613327015904

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R