BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 50MM NO 1

    MDR report key: 3002823 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00981
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MISSING CENTRALIZER INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. IT WAS REPORTED THAT WHEN THE DEVICE WAS OPENED DURING SURGERY, IT WAS FOUND THAT IT DID NOT CONTAIN ANY CENTRALIZERS. THE SALES REP REPORTED THAT THE THEATRE STAFF OPENED A SEPARATELY PACKED CENTRALIZER (PRODUCT CODE: 0920-2-920) TO COMPLETE THE SURGERY AND NO ADVERSE CONSEQUENCES WERE REPORTED. THE SALES REP HOWEVER WAS NOT PRESENT TO CONFIRM THE EVENT. THE EXETER STEM IS SUPPLIED WITH 1 WINGED AND 1 NON-WINGED CENTRALIZER. THE EXETER WINGED CENTRALIZER IS SUPPLIED PACKAGED WITH THE EXETER STEM AND ALSO SUPPLIED AS A SEPARATELY PACKAGED COMPONENT 'EXETER WINGED CENTRALIZER 0920-2-920'.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT WHEN THE DEVICE WAS OPENED DURING SURGERY, IT WAS FOUND THAT IT DID NOT CONTAIN ANY CENTRALISERS. THE SALES REP REPORTED THAT THE THEATRE STAFF OPENED A SEPARATELY PACKED CENTRALISER (PRODUC CODE: 0920-2-920) TO COMPLETE THE SURGERY AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT WHEN THE DEVICE WAS OPENED DURING SURGERY, IT WAS FOUND THAT IT DID NOT CONTAIN ANY CENTRALISERS. THE SALES REP REPORTED THAT THE THEATRE STAFF OPENED A SEPARATELY PACKED CENTRALISER (PRODUC CODE: 0920-2-920) TO COMPLETE THE SURGERY AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105573 EXETER V40 STEM 50MM NO 1 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G3336126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other