BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 21974669 · Received May 7, 2025

    Report

    Report Number
    3005180920-2025-00367
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 12, 2025
    Report Date
    May 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030811838
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-APR-2025. LOT 2409184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2024. EXPIRATION DATE: 14-APR-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 14-APR-2025: COCR 01.25.025 COCR BALL HEAD 12/14 Ø 32 SIZE XXL +10.5 (K072857) LOT 2304109: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 15-APR-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 11 DAYS AFTER PRIMARY, THE PATIENT CAME IN REPORTING RECURRENT JOINT LUXATION. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA IMPLANTS AND IMPLANTED STRYKER MDM CUP WITH CEMENTED STEM VIA A POSTERIOR APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423216 MPACT ACETABULAR SYSTEM MPACT HOODED PE HC LINER Ø32/C LZO MEDACTA INTERNATIONAL SA 01.32.3239HCAT 2409184 07630030811838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention