BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULT*METAL CUP INNER 0DG 28/52

    MDR report key: 16823901 · Received April 27, 2023

    Report

    Report Number
    1818910-2023-08861
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    January 1, 2023
    Report Date
    April 27, 2023
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY; NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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; THE LOT 1052079 DOES NOT REFLECT A VALID FINISHED GOODS LOT NUMBER. THEREFORE, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO VALID FINISHED GOODS LOT NUMBER WAS PROVIDED FOR THIS DEVICE. CORRECTED D4.

    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.

    Description of Event or Problem · 0

    SURGEON IS ORDERING A PATIENT SPECIFIC PE INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR RIGHT SIDE. DOI: > 10 YRS AGO. DOR: PLANNED AS SOON AS PATIENT SPECIFIC IMPLANT WILL BE MANUFACTURED BY DEPUY IN SPRING/SUMMER 2023. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461714 ULT*METAL CUP INNER 0DG 28/52 HIP ACETABULAR LINERS LPH DEPUY INTERNATIONAL LTD - 8010379 1052079

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention