BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT HC PE FIXED FLAT LINER 36

    MDR report key: 3764732 · Received April 9, 2014

    Report

    Report Number
    3005180920-2014-00040
    Event Type
    Injury
    Date Received
    April 9, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103721
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: MPACT HC UHMWPE ACETABULAR LINER SIZE 36E: REF. 01.32.3644HCT/ LOT 132131 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. MPACT ACETABULAR SHELL TWO HOLES SIZE 50: REF. 01.32.050DH/ LOT 132790 ((B)(4) SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE INFORMATION COLLECTED, THE EVENT IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REFERENCE IMPORTER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213312 MPACT HC PE FIXED FLAT LINER 36 ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1