BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 50MM

    MDR report key: 3870649 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02259
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN TRIDENT CUP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED IN THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    UPDATE 6/30: THE CUP AND INSERT WERE DISLOCATED BECAUSE THE INSERT AND HEAD WERE DISLOCATED WHEN THE DOCTOR WAS REPOSITIONED

    Description of Event or Problem · 1

    AT (B)(6) 2014, THE THA WAS DONE WITH SSF STEM AND TRIDENT CUP AND TRIDENT 0° X3 INSERT, 26MM V40 HEAD. AFTER THIS, THE REVISION SURGERY WITH POLYETHYLENE CUP AND V40 HEAD WERE DONE AT (B)(6) 2014, BECAUSE THE CUP AND INSERT WERE DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347860 TRIDENT PSL HA CLUSTER 50MM IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH 46210601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention