BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 52MM

    MDR report key: 3781182 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01673
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT SHELL WAS REPORTED. THE REPORTED EVENT DOES NOT ALLEGE A FAILURE WITH THE REPORTED SHELL, RATHER A DISLOCATION BETWEEN THE HEAD AND LINER. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, NOR ADDITIONAL INFORMATION MADE AVAILABLE DUE TO HOSPITAL POLICY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS RIGHT HIP WAS REVISED DUE TO DISLOCATION. THE SURGEON DID NOT MAKE ANY INTRAOPERATIVE COMMENTS. THE SALES REP ASKED THE REVISION SURGEON IF HE HAD ANY FURTHER INFORMATION REGARDING THE FIRST REVISION. HE STATED THAT THE REVISION OF THE PRIMARY WAS DONE OUT OF THEIR AREA AND HE DOES NOT HAVE ADDITIONAL INFORMATION. NO FURTHER INFORMATION WILL BE MADE AVAILABLE TO THE SALES REP FROM THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS RIGHT HIP WAS REVISED DUE TO DISLOCATION. THE SURGEON DID NOT MAKE ANY INTRAOPERATIVE COMMENTS. THE SALES REP ASKED THE REVISION SURGEON IF HE HAD ANY FURTHER INFORMATION REGARDING THE FIRST REVISION. HE STATED THAT THE REVISION OF THE PRIMARY WAS DONE OUT OF THEIR AREA AND HE DOES NOT HAVE ADDITIONAL INFORMATION. NO FURTHER INFORMATION WILL BE MADE AVAILABLE TO THE SALES REP FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260742 TRIDENT PSL HA CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R