BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG X3 INSERT 32MM HEAD

    MDR report key: 3875100 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02286
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE EVENT TO BE DEBRIS TRAPPED BETWEEN THE MATING FACES OF THE LINER AND SHELL DURING INSERTION AND ATTEMPTED LOCKING. VISUAL INSPECTION THE SUBJECT LINER WAS RETURNED IN USED CONDITION WITH DAMAGES CONSISTENT WITH THE REPORTED IMPLANTATION ATTEMPT. CONFIRMING THE EVENT. MINOR GOUGING DAMAGE ON THE LOCKING FEATURE INDICATES DEBRIS WAS PRESENT BETWEEN THE MATING FACES OF THE LINER AND SHELL DURING INSERTION AND ATTEMPTED LOCKING. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    WE IMPLANTED A 50MM TRITANIUM CLUSTER CUP ALPHA CODE D. WE WENT TO IMPLANT A TRIDENT 32 NEUTRAL X3 POLYETHYLENE LINER AND IT WOULD NOT GO IN THE CUP. IT WOULD NOT SEAT PROPERLY IN THE CUP. WE PLACED A 32 D LINER TRIAL IN TO MAKE SURE IT WASN'T THE CUP THAT WAS GIVING US THE ISSUE AND IT WENT IN EASILY. WE OPENED A NEW LINER SAME SIZE AND ALPHA CODE MADE IT WORKED PERFECTLY.

    Description of Event or Problem · 1

    WE IMPLANTED A 50MM TRITANIUM CLUSTER CUP ALPHA CODE D. WE WENT TO IMPLANT A TRIDENT 32 NEUTRAL X3 POLYETHYLENE LINER AND IT WOULD NOT GO IN THE CUP. IT WOULD NOT SEAT PROPERLY IN THE CUP. WE PLACED A 32 D LINER TRIAL IN TO MAKE SURE IT WASN'T THE CUP THAT WAS GIVING US THE ISSUE AND IT WENT IN EASILY. WE OPENED A NEW LINER SAME SIZE AND ALPHA CODE MADE IT WORKED PERFECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352209 TRIDENT 0 DEG X3 INSERT 32MM HEAD IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MNE2W3

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other