BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    MDR report key: 7804983 · Received August 22, 2018

    Report

    Report Number
    3005180920-2018-00623
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 21, 2018
    Report Date
    August 22, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 AUGUST 2018. LOT 174267: 70 ITEMS MANUFACTURED AND RELEASED ON 05 DECEMBER 2017. EXPIRATION DATE: 2022-11-22 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 67 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 PAIN 3 MONTHS AFTER PRIMARY SURGERY. THE SURGEON DETERMINED THAT THE CUP WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647091 MPACT ACETABULAR SHELL Ø50 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 174267 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention