BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE

    MDR report key: 15328042 · Received August 31, 2022

    Report

    Report Number
    3005180920-2022-00663
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 31, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08-AUG-2022: LOT 1811195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2019. EXPIRATION DATE: 2024-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180018 CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE HIP ACETABULAR CUP CEMENTLESS LPH MEDACTA INTERNATIONAL SA 1811195

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention