BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI MENTUM ALTRX LNR 53 28

    MDR report key: 22979715 · Received September 5, 2025

    Report

    Report Number
    1818910-2025-15341
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 18, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LZO
    UDI-DI
    10603295525240
    PMA / PMN Number
    K203532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 MEDWATCH, A FOLLOW-UP MEDWATCH 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. A SEARCH OF THE MEDTECH ORTHOPAEDICS (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 122128053, LOT - 4040006) COMBINATION. 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- A SEARCH OF THE MEDTECH ORTHOPAEDICS (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT (PRODUCT CODE: 122128053, LOT - 4040006) COMBINATION. H11 ADDITIONAL NARRATIVE: ADDED: D10.

    Description of Event or Problem · 0

    PATIENT WAS REVISED DUE TO INFECTION, THE HEAD, LINER AND PROXIMAL BODY WERE REMOVED AND REPLACED AFTER WASHOUT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224961 BI MENTUM ALTRX LNR 53 28 HIP IMPLANT - ACETABULAR LINER LZO DEPUY IRELAND - 3015516266 4040006 10603295525240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention DELTA CER HEAD 12/14 28MM +1.5.| PINNACLE DM LINER 62_53.| RECLAIM PRX BDY CONE 24X85.