BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 35.5MM

    MDR report key: 3023662 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01097
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PATIENT IS 16(B)(6) IN HEIGHT. AN EVENT REGARDING DAMAGE INVOLVING AN EXETER DEVICE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. CONCLUSIONS: THE EXACT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. IT WAS REPORTED THAT A SUPERFICIAL SCRATCH WAS VISIBLE ON THE STEM APPROXIMATELY 5CM FROM THE DISTAL TIP TOWARDS THE LATERAL SIDE. NEITHER PHOTOS OR THE DEVICE WERE PROVIDED FOR EVALUATION AND IT IS NOT POSSIBLE TO CONFIRM IF THE MARK WAS A SCRATCH OR INVESTIGATE THE POTENTIAL CAUSE FOR THE MARK. A REVIEW OF THE MANUFACTURING CONTROLS WAS COMPLETED BY THE SUPPLIER AND THERE IS 100% INSPECTION PERFORMED ON THE DEVICES PRIOR TO RELEASE. A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE IFU ALSO INDICATES THAT THE HIGHLY POLISHED PORTION OF THE IMPLANT SHOULD NOT COME IN CONTACT WITH HARD SURFACES.

    Description of Event or Problem · 1

    ON OPENING THE STERILE IMPLANT FROM PACKAGING, IT WAS IMMEDIATELY NOTICED BY THE SCRUB NURSE AND CONFIRMED BY SURGEON AND STRYKER CNC THAT THERE WAS A NOTICEABLE SCRATCH ON THE STEM THAT WAS MEASURED TO BE APPROXIMATELY 8MM IN LENGTH. PRODUCT WAS IMPLANTED AS THE NEAREST REPLACEMENT IMPLANT WAS AT LEAST AN HOUR AWAY.

    Description of Event or Problem · 1

    ON OPENING THE STERILE IMPLANT FROM PACKAGING, IT WAS IMMEDIATELY NOTICED BY THE SCRUB NURSE AND CONFIRMED BY SURGEON AND STRYKER CNC THAT THERE WAS A NOTICEABLE SCRATCH ON THE STEM THAT WAS MEASURED TO BE APPROXIMATELY 8MM IN LENGTH. PRODUCT WAS IMPLANTED AS THE NEAREST REPLACEMENT IMPLANT WAS AT LEAST AN HOUR AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126012 EXETER V40 STEM 35.5MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G3246805

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other