BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø52 NO-HOLE

    MDR report key: 16893409 · Received May 9, 2023

    Report

    Report Number
    3005180920-2023-00347
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 9, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810817
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 2 APRIL 2023: LOT 2243239: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2023. EXPIRATION DATE: 2028-01-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: REVISION SURGERY 2 MONTHS AFTER PRIMARY THA DUE TO SHELL MOBILIZATION IN A 64 YEAR OLD FEMALE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. FROM THE RADIOGRAPHIC IMAGES, THE ACETABULAR CUP APPEARS TO HAVE MOBILIZED. IN THESE CONDITIONS, IT IS VERY LIKELY THAT PART OF THE FEMORAL STEM MAY IMPINGE WITH THE ACETABULAR RIM AND DAMAGE MAY OCCUR. THE CUP HAS NOT FOUND PRESSFIT AND PRIMARY STABILITY AND THE REASON OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 2 MONTHS POST PRIMARY FOLLOWING SHELL MOBILIZATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599877 MPACT ACETABULAR SHELL Ø52 NO-HOLE HIP CEMENTLESS SHELL LPH MEDACTA INTERNATIONAL SA 01.32.152SH 2243239 07630030810817

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention