BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP 01.26.46MB ACETABULAR SHELL Ø 46

    MDR report key: 15335950 · Received September 1, 2022

    Report

    Report Number
    3005180920-2022-00654
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    August 2, 2022
    Report Date
    September 1, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808012
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04-AUG-2022 LOT 181686: 15 ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2018. EXPIRATION DATE: 2023-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 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 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830832 CUP: VERSAFITCUP 01.26.46MB ACETABULAR SHELL Ø 46 HIP ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 01.26.46MB 181686 07630030808012

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention