BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #5

    MDR report key: 2925468 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00163
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT.THIS EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF THE LIMITED INFORMATION PROVIDED. FURTHER INFORMATION SUCH AS THE RETURNED PRODUCT AND A COMPLETE SET OF MEDICAL RECORDS ARE NEEDED TO FULLY INVESTIGATE THIS EVENT. (B)(4): NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN IN KNEE, X-RAYS SHOW LOOSENING AROUND TIBIAL BASEPLATE, UPON REMOVING THE TIBIAL BASEPLATE SURGEON NOTICED NO CEMENT HAD BEEN ATTACHED TO TIBIAL BASEPLATE. REMOVED OLD CEMENT, PREPPED TIBIAL FOR NEW TIBIAL COMPONENT, TRIALED WITH TRIAL COMPONENTS, COMPONENTS SEEMED SATISFACTORY TO SURGEON, OPENED NEW COMPONENTS AND CEMENTED THEM INTO PATIENT'S PATELLA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN IN KNEE, X-RAYS SHOW LOOSENING AROUND TIBIAL BASEPLATE, UPON REMOVING THE TIBIAL BASEPLATE SURGEON NOTICED NO CEMENT HAD BEEN ATTACHED TO TIBIAL BASEPLATE. REMOVED OLD CEMENT, PREPPED TIBIAL FOR NEW TIBIAL COMPONENT, TRIALED WITH TRIAL COMPONENTS, COMPONENTS SEEMED SATISFACTORY TO SURGEON, OPENED NEW COMPONENTS AND CEMENTED THEM INTO PATIENT'S PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30512 TRIATHLON PRIM CEM FXD BPLT #5 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH SJ6CS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention