BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52

    MDR report key: 19749121 · Received July 16, 2024

    Report

    Report Number
    3005180920-2024-00548
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860973
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 3 JULY 2024: LOT 2317983: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2024. EXPIRATION DATE: 2029-01-31. 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 COMPONENT INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 3 JULY 2024: LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT 2343972: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2024. EXPIRATION DATE: 2029-01-03. 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

    REVISION SURGERY AT 1 WEEK FROM PRIMARY, SHELL, HEAD AND LINER REVISED SUCCESSFULLY. THE PATIENT LUXATED HIS HIP AND SUSTAINED A CLOSED REDUCTION, BUT AFTER THIS, IN THE X-RAYS DONE IN THE ER, IT WAS NOTICED THAT THE SHELL WAS OUT OF THE ACETABULUM BONE. IT IS UNKNOWN IF THE LUXATION WAS DUE TO THE CUP FAILURE OR IF THE CUP FAILURE WAS GENERATED DURING THE CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722961 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52 HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 2317983 07630030860973

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention