BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 20479341 · Received October 18, 2024

    Report

    Report Number
    3005180920-2024-00843
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 SEPTEMBER 2024: LOT 2310238: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2023. EXPIRATION DATE: 2028-MAY-21. 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 IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 20 SEPTEMBER 2024: CUP: MPACT 01.32.150DH ACETABULAR SHELL Ø50 TWO-HOLES (K132879) LOT 2349366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2024. EXPIRATION DATE: 2029-MAY-30. 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

    THE LINER COULD NOT BE PLACED INTO THE CUP. DURING LINER IMPACTION ATTEMPTS, THE CUP CHANGED POSITION, SO IT HAD TO BE REPOSITIONED AND THE SCREW ALREADY PLACED WAS REMOVED. CUP WAS WELL FIXED AND WAS IMPLANTED WITH NO SCREW, AS THE ORIENTATION OF THE SCREW HOLES MADE DRILLING DIFFICULT. A NEW LINER WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ABOUT 20 MINUTES DELAY OCCURRED DUE TO THE ISSUE; TOTAL SURGERY TIME 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716963 MPACT ACETABULAR SYSTEM FLAT PE HC LINER Ø 32 / D LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 2310238 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other