BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY HC LINER 22.2/DMB

    MDR report key: 7446814 · Received April 20, 2018

    Report

    Report Number
    3005180920-2018-00254
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    March 23, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030806803
    PMA / PMN Number
    K131458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 APRIL 2018. LOT 155391: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 JANUARY 2016. EXPIRATION DATE: 2020-12-09. NO ANOMALIES FOUND RELEATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AMISTEM H REFERENCE 01.18.098 (K121011) HA COATED STD STEM SIZE 00; LOT 122915A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 DECEMBER 2017. EXPIRATION DATE: 2022-11-21. NO ANOMALIES FOUND RELEATED TO THE ISSUE. TO DATE, ONLY THIS ITEM OF THE LOT HAS BEEN SOLD. REFERENCE 01.25.123 (K080885) COCR BALL HEAD 12/14 Ø 22 SIZE M 0; LOT 163199: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 AUGUST 2016. EXPIRATION DATE: 2021-07-19. NO ANOMALIES FOUND RELEATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REFERENCE 01.32.144MB (K143453) DOUBLE MOBILITY ACETABULAR SHELL Ø44; LOT 166633: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 FEBRUARY 2017. EXPIRATION DATE: 2022-02-12. NO ANOMALIES FOUND RELEATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 19 APRIL 2018; THE IMPLANT SHOWS SCRATCHES ON THE NECK AND TRUNNION OF THE FEMORAL STEM AND SCRATCHES ON THE EDGE AND ARTICULATING SURFACE OF THE ACETABULAR CUP. ALL OF THEM WERE CAUSED BY EXTRACTION PROCEDURE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 20 APRIL 2018 EARLY INFECTION IN CEMENTLESS THA, 3 DAYS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    THREE DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION IMPLANTING A SPACER MADE BY: MASTERLOC STEM, COCR HEAD, CEMENTING MPACT LINER AND USING A COMPETITOR SPACER FOR THE ACETABULUM. ON THE (B)(6) 2018 THE SURGEON SWAPPED THE SPACED WITH DEFINITIVE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289225 MPACT DOUBLE MOBILITY HC LINER 22.2/DMB DOUBLE MOBILITY HC LINER LZO MEDACTA INTERNATIONAL SA 155391 07630030806803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention