BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 28G

    MDR report key: 3060994 · Received April 16, 2013

    Report

    Report Number
    0002249697-2013-01334
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED AS THE REPORTED DEVICE WAS NOT PROVIDED FOR EVALUATION. PATIENT MEDICAL RECORDS WERE PROVIDED TO A CONSULTING CLINICIAN FOR REVIEW WHO DEEMED THE INFORMATION INSUFFICIENT TO DETERMINE A ROOT CAUSE. HOWEVER, THE X-RAY PROVIDED DID CONFIRM THE REPORTED DISLOCATION OF THE CONSTRAINED LINER. DEVICE HISTORY REVIEW: INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE PROVIDED LOT ID. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED FALLING DOWN. CONSTRAINED LINER HAS DISLOCATED.

    Description of Event or Problem · 1

    PATIENT REPORTED FALLING DOWN. CONSTRAINED LINER HAS DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161943 TRIDENT 0 DEG CONSTRAINED INSERT 28G IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH MLP8KT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention