BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM CEM FXD BPLT #5

    MDR report key: 4827981 · Received June 9, 2015

    Report

    Report Number
    0002249697-2015-01861
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED MALPOSITION 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: INSUFFICIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW BY A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: DHR REVIEW FOR THIS LOT WAS SATISFACTORY. COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE BEEN NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT PROVISION OF INFORMATION. FURTHER INFORMATION SUCH AS PRIMARY & REVISION OPERATIVE REPORTS AND CT SCAN IF AVAILABLE ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE, AS PER A CLINICAL CONSULTANT SUGGESTION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER

    Description of Event or Problem · 1

    THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. THE SURGEON COMMENTED THAT THE TIBIA WAS INTERNALLY ROTATED AND HAD EXCESSIVE SLOPE USING AN ORTHOSENSOR (TM).

    Description of Event or Problem · 1

    THE PATIENTS' RIGHT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. THE SURGEON COMMENTED THAT THE TIBIA WAS INTERNALLY ROTATED AND HAD EXCESSIVE SLOPE USING AN ORTHOSENSOR¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373018 TRIATHLON PRIM CEM FXD BPLT #5 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH EKD7A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention