BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4

    MDR report key: 8045556 · Received November 7, 2018

    Report

    Report Number
    3005180920-2018-00860
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    October 13, 2018
    Report Date
    November 7, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803215
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 NOVEMBER 2018. LOT 122208: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 SEPTEMBER 2012. EXPIRATION DATE: 2017-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED ON NOVEMBER 06, 2018 BY MEDICAL AFFAIRS DIRECTOR. 5 YEARS AFTER REVISION HIP ARTHROPLASTY THE FEMORAL STEM, WHICH HAD BEEN LEFT IN PLACE AT REVISION, BROKE OFF AT THE NECK LEVEL. THE EXPLANTS HAVE NOT BEEN RECEIVED SO THEY COULD NOT BE ANALYZED. FROM THE PICTURES SENT, IT APPEARS THAT THE FRACTURE MAY HAVE STARTED LATERALLY AND LOOKS LIKE A FATIGUE FRACTURE, BUT OF COURSE THE DOCUMENTATION IS NOT SUFFICIENT FOR A FINAL ASSESSMENT. HOWEVER, THE EXPERIENCE SHOWS THAT THIS KIND OF FRACTURES, EXTREMELY RARE, ARE ALMOST ALWAYS CAUSED BY A DAMAGED INFLICTED UPON THE PROSTHESIS NECK DURING THE FIRST REVISION OPERATION. OFTEN THE ELECTROCAUTER IS THE CAUSE OF SUCH DAMAGES. BASED ON THIS EXPERIENCE, MEDACTA ISSUED A FIELD SAFETY NOTICE IN FEBRUARY 2013, A FEW MONTHS BEFORE THE FIRST REVISION OPERATION OF THIS CASE, WARNING AGAINST ACCIDENTAL IMPLANT DAMAGE DURING REVISION SURGERY THAT LEAVES SOME COMPONENTS IN PLACE. A FINAL DECISION ON THE ROOT CAUSE OF THE FAILURE CANNOT BE EXPRESSED BECAUSE THE EXPLANTS WERE NOT RETURNED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON NOVEMBER 05, 2018. IMPLANT SHOWS FATIGUE FRACTURE OF FEMORAL NECK AND SEVERAL UNKNOWN MARKS AND PITS ON THE NECK REGION. DEEP SCRATCH ON THE STEM DUE TO EXTRACTION. VISUAL INVESTIGATION OF THE COMPONENT IS NECESSARY TO DETERMINE FAILURE ROOT CAUSE. SINCE THE PATIENT UNDERWENT HEAD, LINER AND SHELL REVISION IN (B)(6) 2013 IT IS POSSIBLE THAT THE NECK FAILURE COULD BE RELATED TO POSSIBLE DAMAGES DUE TO ELECTROSURGICAL UNIT. IF THE ELECTRODE COMES INTO CONTACT WITH THE FEMORAL STEM, IT MAY INTRODUCE SURFACE CRACKS THAT WITH TIME MAY LEAD TO FRACTURE ON THE INTERESTED REGION. IN APRIL 2013 MEDACTA INFORMED ALL CLIENTS ON THE POSSIBLE RISKS OF REVISION SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    WE WERE INFORMED ON (B)(4) 2018 THAT ON (B)(6) 2018 THE PATIENT WENT TO THE HOSPITAL SINCE HE HEARD A NOISE AND THE ARTICULATION IS NOT STABLE. PATIENT WAS REVISED DUE TO HIP LUXATION IN 2013, CUP, HEAD AND LINER WERE REMOVED. IN 2018 THE PATIENT WAS REVISED AGAIN DUE TO NECK STEM BREAKAGE. STEM AND HEAD WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887623 MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 122208 07630030803215

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention