BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI MENTUM ALTRX LNR 45 22

    MDR report key: 20400350 · Received October 8, 2024

    Report

    Report Number
    1818910-2024-21096
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 30, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LZO
    UDI-DI
    10603295525370
    PMA / PMN Number
    K203532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION- BI MENTUM ALTRX LNR 45 22 PRODUCT CODE-122122045 LOT NO- 3981196 QUANTITY OF MANUFACTURED- 28 DATE OF MANUFACTURING- 26-OCT-2022 EXPIRY DATE-30-SEP-2027 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 PRODUCT DESCRIPTION- BI MENTUM ALTRX LNR 45 22 PRODUCT CODE-122122045 LOT NO- 3981196 QUANTITY OF MANUFACTURED- 28 DATE OF MANUFACTURING- 26-OCT-2022 EXPIRY DATE-30-SEP-2027 DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3981196] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH DRAINAGE POST THA AFTER BEING DIAGNOSED WITH UNCONTROLLED DIABETES. PATIENT ALSO HAS CIRRHOSIS OF THE LIVER. AN I&D WITH MODULAR COMPONENT EXCHANGE WAS PERFORMED WITHOUT DELAY NOR PATIENT HARM. NO ALLEGATION IS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22795 BI MENTUM ALTRX LNR 45 22 HIP IMPLANT - ACETABULAR LINER LZO DEPUY IRELAND - 3015516266 3981196 10603295525370

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention