BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT ACETABULAR PE LINER Ø 36

    MDR report key: 5152738 · Received October 15, 2015

    Report

    Report Number
    3005180920-2015-00240
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 16, 2015
    Report Date
    November 19, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 29 OCTOBER 2015 THE R&D JOINTS DIRECTOR MADE THE FOLLOWING ANALYSIS ON THE RETRIEVED IMPLANTS: THE METALLIC SHELL AND THE PE LINER HAVE BEEN VISUALLY INSPECTED. THERE IS NOTHING TO BE REPORTED. WITH THE DEDICATED INSTRUMENT THE PE LINER CAN BE EASILY FULLY INSERTED. ON 19 NOVEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND HERE ABOVE. ON THE SAME DATE THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 OCTOBER 2015: LOT 140553: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 APRIL 2014. EXPIRATION DATE: 2019-02-28. 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. MPACT ACETABULAR SHELL Ø56 TWO-HOLES REF. 01.32.156DH LOT. 135868 (K132879): LOT 135868: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 MY 2014. EXPIRATION DATE: 2019-04-30. 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. NOT RECEIVED YET.

    Description of Event or Problem · 1

    LINER WOULD NOT FULLY SEAT IN THE SHELL. AFTER MULTIPLE ATTEMPTS TO SEAT THE LINER IT REMAINED PROUD BY 1MM. THE SURGERY WAS DELAYED BY 10-15 MINUTES. THE SURGEON REPLACED BOTH THE CUP AND LINER THAT FIT CORRECTLY. THE EXPLANTS WILL BE RETURNED. THERE ARE NO X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682576 MPACT ACETABULAR PE LINER Ø 36 ACETABULAR PE LINER LPH MEDACTA INTERNATIONAL SA 140553

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other