BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50

    MDR report key: 17753999 · Received September 15, 2023

    Report

    Report Number
    3005180920-2023-00739
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 22, 2023
    Report Date
    September 15, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860966
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 SEP 2023 LOT 2110837: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 09-FEB-2022. EXPIRATION DATE: 2027-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 13 SEP 2023: STEM: AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD STEM SIZE 2 (K173794) LOT 2108021: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2021. EXPIRATION DATE: 2026-10-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO IMPINGEMENT BETWEEN CUP AND STEM CAUSING PAIN AND INSTABILITY. THE SURGEON REVISED THE HEAD (S TO XL) AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039678 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50 HIP DOUBLE MOBILITY CUP LPH MEDACTA INTERNATIONAL SA 2110837 07630030860966

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention