BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50

    MDR report key: 14344591 · Received May 10, 2022

    Report

    Report Number
    3005180920-2022-00359
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860966
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 2012851: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2021. EXPIRATION DATE: 2026-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT DM 01.26.2850MHC DOUBLE MOBILITY HC LINER 28/DME (K092265) LOT. 2102557 BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 2102557: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2021. EXPIRATION DATE: 2026-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A CUP IMPINGEMENT, THERE WAS A LOT OF TISSUE SURROUNDING THE CUP. AT 7 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE MEDACTA CUP TO A COMPETITOR CUP AND REVISED THE MEDACTA HEAD AND LINER TO A MEDACTA HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565988 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50 CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150MB 2012851 07630030860966

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention