BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC STEM TRIAL EXTRACT

    MDR report key: 8625388 · Received May 20, 2019

    Report

    Report Number
    1818910-2019-94066
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 1, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWB
    UDI-DI
    10603295216766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED DAMAGE. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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

    WHEN RESETTING INSTRUMENT TRAYS FROM THE DAYS PRIOR REVISION CASE THE SIGMA SIZE 4 POSTERIOR AUGMENT (8MM) BROKE OFF IN THE SIGMA SIZE 4 FEMORAL TRIAL. I ALSO HAD THE TRIAL EXTRACTOR FOR THE SIGMA UNIVERSAL STEMS BEND AND IS NOT LONGER USABLE. THE PATIENT WAS NOT AFFECTED BY THIS SINCE THIS ALL OCCURRED POST OP, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418607 PFC STEM TRIAL EXTRACT HIP INSTRUMENTS : FEMORAL TRIALS HWB DEPUY ORTHOPAEDICS, INC. 1818910 G0408 10603295216766

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR