BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    MDR report key: 10051296 · Received May 13, 2020

    Report

    Report Number
    3005180920-2020-00279
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    April 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 24 APRIL 2020: LOT 1902271: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2019. EXPIRATION DATE: 2024-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING PAIN 6 MONTH AFTER THE PRIMARY SURGERY. THE SURGEON OBSERVED FROM X-RAYS THAT THE PATIENT'S CUP HAD TOO MUCH ANTEVERSION. THE SURGEON REVISED THE CUP, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517344 CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.152DH 1902271 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention