BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #2

    MDR report key: 8055491 · Received November 9, 2018

    Report

    Report Number
    0002249697-2018-03671
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    July 11, 2018
    Report Date
    November 9, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327041569
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS INVALID. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS INVALID. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, PATHOLOGY REPORTS, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    HOSPITAL PRACTITIONER REPORTED TO ANSM THE FOLLOWING EVENT : "PREVIOUSLY PRE-COATED OF A TIBIAL IMPLANT OF PTG. ELIMINATION OF AN INFECTION, CHANGED IN APPEARANCE OF THE POLYETHYLINE TIBIAL PLATEAU THAT IS YELLOW". UPDATE OF DESCRIPTION OF THE INCIDENT: EARLY LOOSENING 1 YEAR OF A PTG TIBIAL IMPLANT. ELIMINATION OF AN INFECTION. CURRENT PATIENT STATUS: RE-OPERATION WITH PTG RECOVERY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894916 TRIATHLON PRIM CEM FXD BPLT #2 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327041569

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R