BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ROM*STEM BODY TRIAL 16

    MDR report key: 16251670 · Received January 27, 2023

    Report

    Report Number
    1818910-2023-02109
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 16, 2023
    Report Date
    January 27, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295172796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. REVIEW OF IMAGES PROVIDED ALONG WITH VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE MISALIGNMENT OF THE ENGRAVED LINE IN RELATION TO THE TOOTH PEAK OF THE STAR GRIND. 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 : NR-0191651 WAS LAUNCHED IN DEPUY SYNTHES QUALITY SYSTEMS. THE ENGRAVED, LONGITUDINAL CENTER LINE IS IN CENTER ALIGNMENT WITH THE TOOTH PEAK OF THE STAR GRIND.

    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 SYNTHESE 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 SYNTHESE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE S-ROM TRIAL STEM BODY 16 IN QUESTION WAS OUT OF MIDLINE (LINE OF 0-DEGREE ANTEROPOSTERIOR TWIST) WHEN MATED WITH A NECK TRIAL. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470194 S-ROM*STEM BODY TRIAL 16 HIP INSTRUMENTS : FEMORAL TRIALS HWT DEPUY ORTHOPAEDICS INC US 53-6316 SO2053448 10603295172796

    Patients

    Seq Age Sex Outcome Treatment
    1 Female