BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUR OPT LPW POLY INS 28/58,60

    MDR report key: 18649905 · Received February 6, 2024

    Report

    Report Number
    1818910-2024-02449
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 1, 2023
    Report Date
    February 6, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    UDI-DI
    10603295065678
    PMA / PMN Number
    K040544
    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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY :NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DHR REVIEW : PRODUCT DESCRIPTION: DUR OPT LPW POLY INS 28/58,60. PRODUCT CODE: 159923058. LOT NUMBER: 1177167. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 2/26/2004. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO. 4) EXPIRY DATE: 2/19/2009. 5) IFU REFERENCE: IFU-0902-00-825. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT : DHR REVIEW : PRODUCT DESCRIPTION: DUR OPT LPW POLY INS 28/58,60. PRODUCT CODE: 159923058. LOT NUMBER: 1177167. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 2/26/2004. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO. 4) EXPIRY DATE: 2/19/2009. 5) IFU REFERENCE: IFU-0902-00-825.

    Description of Event or Problem · 0

    SURGEON IS ORDERING A PATIENT SPECIFIC HIP-INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR LEFT SIDE. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY. DOI: 2004. DOR: PLANNED AS SOON AS PATIENT SPECIFIC IMPLANT WILL BE MANUFACTURED BY DEPUY IN SPRING 2024. LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482180 DUR OPT LPW POLY INS 28/58,60 DURALOC OPTION IMPLANTS : HIP POLY ACETABULAR LINERS LPH DEPUY INTERNATIONAL LTD - 8010379 1177167 10603295065678

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention