BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781253 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01624
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS DESCRIBED AS AN UNKNOWN TRIDENT CUP IMPACTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DIFFICULTY RE-ASSEMBLING THE TRIDENT CUP IMPACTOR WITH AN IMPLANTED TRIDENT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO PATIENT FACTORS. CONCLUSIONS: THE REPORTED EVENT DOES NOT SPECIFY WHY THE SURGEON NEEDED TO REATTACH THE IMPACTOR HANDLE TO THE ACETABULAR SHELL. REGARDLESS OF THE REASON, ALIGNMENT OF THE IMPACTOR TO THE ACETABULAR SHELL THREADS WOULD REQUIRE VISUALIZATION OF THE SHELL WHICH IS THE RESPONSIBILITY OF THE SURGICAL TEAM. IT IS NOTED THAT AN ALIGNMENT GUIDE (CATALOG: 2101-0210) EXISTS TO ASSIST THE SURGEON IN POSITIONING THE SHELL CORRECTLY DURING INITIAL IMPLANTATION, REDUCING THE CHANCE THAT THE IMPACTOR WOULD BE NEEDED TO REALIGN THE SHELL. IN THE EVENT THE SHELL REQUIRES FURTHER IMPACTION TO SEAT FULLY, AN ALTERNATIVE INSTRUMENT (CATALOG: 2101-0130) EXISTS TO IMPACT THE SHELL WITHOUT NEEDING TO BE THREADED INTO THE SHELL. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON SAID THAT IT WAS DIFFICULT TO REINTRODUCE TRIDENT CUP IMPACTOR BACK INTO CUP WHEN INSITU IN PATIENT. HE WOULD LIKE TO SEE SOME SORT OF ALIGNMENT GUIDE FOR THIS PURPOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON SAID THAT IT WAS DIFFICULT TO REINTRODUCE TRIDENT CUP IMPACTOR BACK INTO CUP WHEN INSITU IN PATIENT. HE WOULD LIKE TO SEE SOME SORT OF ALIGNMENT GUIDE FOR THIS PURPOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259270 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other