BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT CONSTRAINED INSERT

    MDR report key: 3120439 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01702
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    P960047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT CONSTRAINED INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. 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 REVISION OF A CONSTRAINED LINER AND METAL HEAD DUE TO DISLOCATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED. IN ORDER TO COMPLETE A FULL INVESTIGATION, ITEMS SUCH AS OPERATIVE NOTES, X-RAYS, AND PATIENT HISTORY ARE NEEDED TO DETERMINE THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF A RIGHT CONSTRAINED LINER AND METAL HEAD IN HIP. THE REASON FOR THE REVISION IS DISLOCATION OF THE HEAD OUT OF THE LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF A RIGHT CONSTRAINED LINER AND METAL HEAD IN HIP. THE REASON FOR THE REVISION IS DISLOCATION OF THE HEAD OUT OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222594 TRIDENT CONSTRAINED INSERT IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH T93MEA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention