BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø48 TWO-HOLES

    MDR report key: 7338232 · Received March 14, 2018

    Report

    Report Number
    3005180920-2018-00138
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    February 12, 2018
    Report Date
    October 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810732
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    21.10.2019: IT WAS CONFIRMED THAT THE PATIENT IS MALE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018. LOT 170133: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: 2022-04-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM.TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF DISLOCATION 4 MONTHS AFTER PRIMARY. THE SURGEON BELIEVES THERE WAS TOO MUCH ANTEVERSION FROM THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180331 MPACT ACETABULAR SHELL Ø48 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 170133 07630030810732

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention