BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP EM TIBIAL JIG ANKLE CLAMP

    MDR report key: 14743599 · Received June 20, 2022

    Report

    Report Number
    1818910-2022-11273
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 20, 2022
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    HTZ
    UDI-DI
    10603295225348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    PARTIAL KNEE TIBIAL JIG WORN AND NO LONGER WORKING CORRECTLY. MAIN CENTRAL CONNECTOR NOT TIGHTENING FULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845928 HP EM TIBIAL JIG ANKLE CLAMP KNEE INSTRUMENT : ALIGNMENT DEVICES HTZ DEPUY INTERNATIONAL LTD - 8010379 9505-01-229 10603295225348

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown