BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #2

    MDR report key: 4255570 · Received November 17, 2014

    Report

    Report Number
    0002249697-2014-04290
    Event Type
    Injury
    Date Received
    November 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    October 22, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING TIBIAL BASEPLATE SUBSIDENCE INVOLVING A TRIATHLON BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. -DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE INFORMATION THAT WAS PROVIDED. A ROOT CAUSE CANNOT BE DETERMINED WITHOUT MEDICAL RECORDS, X-RAYS, OPERATIVE NOTES AND FOLLOW-UP NOTES.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Description of Event or Problem · 1

    NTX REGISTRY, STUDY PATIENT (B)(6) HAD LEFT KNEE REPLACEMENT ON (B)(6) 2012 WITHIN THE STUDY. COMPLAINTS OF PAIN, INCREASED VALGUS AND DECREASED WALKING DISTANCE SINCE (B)(6) 2014. TIBIAL COMPONENT SUBSIDENCE WAS DIAGNOSED, EXPLANTATION SURGERY PERFORMED ON (B)(6) 2014.

    Description of Event or Problem · 1

    NTX REGISTRY, STUDY PATIENT (B)(6) HAD LEFT KNEE REPLACEMENT ON (B)(6) 2012 WITHIN THE STUDY. COMPLAINTS OF PAIN, INCREASED VALGUS AND DECREASED WALKING DISTANCE SINCE (B)(6) 2014. TIBIAL COMPONENT SUBSIDENCE WAS DIAGNOSED, EXPLANTATION SURGERY PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742440 TRIATHLON PRIM CEM FXD BPLT #2 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH EADMT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R