BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT TWO HOLES CEMENTLESS ACETABULAR CUP

    MDR report key: 4217972 · Received July 29, 2014

    Report

    Report Number
    3005180920-2014-00095
    Event Type
    Injury
    Date Received
    July 29, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: MPACT TWO HOLES ACETABULAR SHELL 56, CODE 01.32.156DH - LOT 132048 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. MPACT HC PE ACETABULAR LINER, CODE 01.32.3648HCT - LOT 130418 ((B)(4) LINER PRODUCED) - K103721: ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. MPACT TWO HOLES ACETABULAR SHELL 58, CODE 01.32.158DH - LOT 132193 ((B)(4) SHELLS PRODUCED) - K132879: ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. MPACT HC PE ACETABULAR LINER, CODE 01.32.3648HCT - LOT 121154 ((B)(4) LINERS PRODUCED) - K103721: ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE PROBLEM IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMPORTER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442885 MPACT TWO HOLES CEMENTLESS ACETABULAR CUP ACETABULAR SHELL SIZE 56 LPH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1