BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAINING STEM INSERTER

    MDR report key: 8835915 · Received July 29, 2019

    Report

    Report Number
    1818910-2019-99462
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 10, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWR
    UDI-DI
    10603295148548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION DEPUY SYNTHES 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. ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    HIP INSTRUMENT PIECE BROKE-RETAINING STEM INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629243 RETAINING STEM INSERTER HIP INSTRUMENTS : INSERTION DEVICES HWR DEPUY ORTHOPAEDICS INC US A0808 10603295148548

    Patients

    Seq Age Sex Outcome Treatment
    1