BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT DM ACETABULAR SHELL

    MDR report key: 7734865 · Received July 31, 2018

    Report

    Report Number
    3005180920-2018-00557
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 31, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030861024
    PMA / PMN Number
    K143453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER ON SEPTEMBER 27, 2018: THE PARTICLES OF COATING WERE WELL VISIBLE IN THE PACKAGE, DETACHED FROM THE IMPLANT. THE DEBRIS WAS PRESENT INSIDE THE BLISTER, IN WHICH MANY SCRATCHES WERE VISIBLE DUE TO THE IMPINGEMENT BETWEEN BLISTER AND DEBRIS. MOREOVER, THE INTERNAL MOUSSE WAS DEFORMED AND WITH A CONSISTENT PRESENCE OF HOLES CAUSED BY DEBRIS. ACCORDING TO THE PRELIMINARY INSPECTION, A POSSIBLE ROOT CAUSE CAN BE RELATED TO A PROBLEM THAT OCCURRED DURING THE TRANSPORTATION. COATING MANUFACTURER ANALYSIS RECEIVED ON OCTOBER 01, 2018: PACKAGING BLISTER IS EVIDENTLY DAMAGED, A POSSIBLE ROOT CAUSE CAN BE RELATED TO A PROBLEM THAT OCCURRED DURING THE TRANSPORTATION.

    Additional Manufacturer Narrative · 1

    ON (B)(6) THE COATING SUPPLIER CHECKED THE BATCH DOCUMENTS WITHOUT FINDING ANY TECHNICAL ANOMALY RELATED TO THE PROCESSES OF BOTH DEVICES. ON (B)(6) THE R&D PROJECT MANAGED ANALYSED THE IMAGES RECEIVED, COMMENTING: IN ALL THE IMAGES, PARTICLES OF COATING CAN BE NOTED INSIDE THE PACKAGING. ALSO THE IMAGE RELATIVE TO THE INTERNAL BLISTER SHOWS EVIDENT DAMAGES AND SCRATCHES. PROBLEM OF TRANSPORTATION CAN BE A REASONABLE REASON TO EXPLAIN THE CONDITION OF BOTH PACKAGING AND IMPLANT. BATCH REVIEW PERFORMED ON (B)(6) 2018: LOT 160433: 19 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-04-12. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 1 ITEM OF THE SAME LOT HAS BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø64 REF. 01.32.164MB LOT. 162394 (K143453): THE 15 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-07-05. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 1 ITEM OF THE SAME LOT HAS BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    DURING SURGERY IT WAS NOTICED THAT 2 IMPLANTS HAD DEBRIS INSIDE THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579188 MPACT DM ACETABULAR SHELL CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 160433 07630030861024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other