BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INS SIZE4 13MM

    MDR report key: 3844144 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-01989
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SEATING LOCKING ISSUES INVOLVING A X3 TRIATHLON CS INS SIZE4 13MM WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICES WERE RETURNED FOR EVALUATION. MEDICAL RECORDS AND EVALUATION INDICATED THAT INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. THE CLINICIAN DID STATE THAT THE X-RAYS SHOW THE LOCKING MECHANISM DISLODGED. DEVICE HISTORY REVIEW INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. THE REPORTED EVENT INVOLVES AN ISSUE WITH THE LOCKING MECHANISM FOR THE POLY INSERT. THE PATIENT RECEIVED A POLY SWAP THE NEXT DAY. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    EVERYTHING WENT ACCORDING TO PLAN IN SURGERY AND NOTHING SEEMED ABNORMAL. THAT AFTERNOON DOCTOR INDICATED TO THE REP THAT THERE MAY BE LOCKING MECHANISM ISSUE WITH THE POLY. PATIENT WAS SCHEDULED FOR POLY SWAP ON THE (B)(6) 2014.

    Description of Event or Problem · 1

    EVERYTHING WENT ACCORDING TO PLAN IN SURGERY AND NOTHING SEEMED ABNORMAL. THAT AFTERNOON DOCTOR INDICATED TO THE REP THAT THERE MAY BE LOCKING MECHANISM ISSUE WITH THE POLY. PATIENT WAS SCHEDULED FOR POLY SWAP ON THE (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322406 X3 TRIATHLON CS INS SIZE4 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LDS546

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention