BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL TAP 7MM

    MDR report key: 8074436 · Received November 15, 2018

    Report

    Report Number
    1020279-2018-02498
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 11, 2018
    Report Date
    March 12, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    UDI-DI
    03596010437631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED CONICAL TAP WAS NOT RETURNED FOR EVALUATION. A CLINICAL EVALUATION CONDUCTED DURING THIS INVESTIGATION NOTED THAT WITHOUT ADDITIONAL RELEVANT CLINICAL INFORMATION OR RETURN OF THE BROKEN INSTRUMENT, THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED. THE POST-OPERATIVE CONDITION OF THE PATIENT IS UNKNOWN AT THIS TIME. AS THE LOCATION OF THE FRAGMENT CANNOT BE CONFIRMED, IT IS UNKNOWN WHETHER MICRO-MOTION COULD OCCUR. THEREFORE, THE FUTURE IMPACT TO THE PATIENT CANNOT BE DETERMINED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED BASED ON THE LIMITED DETAILS PROVIDED. THE DEVICE WAS MANUFACTURED IN 2011. OUR INVESTIGATION INCLUDING A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED FAILURE MODE WITH THE SAME BATCH NUMBER. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED FAILURE MODE WITH THE SAME BATCH NUMBER. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION OF THIS REPORT IS INCONCLUSIVE. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING REVISION SURGERY OF STEM, WHILE REMOVING BONE CEMENT (VERY GENTLY) FROM THE CANAL, THE DISTAL PART OF THE INSTRUMENT WAS BROKEN. A BROKEN PART WAS LEFT IN THE CANAL, LOCATION CONFIRMED BY X-RAYS. AS IT WAS NOT POSSIBLE TO IMPLANT A LONG REVISION STEM, A SHORT ONE WAS USED INSTEAD. THERE WAS A DELAY LONGER THAN 30 MINUTES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913142 CONICAL TAP 7MM PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC. 11BSY0001 03596010437631

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR