BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H PROXIMAL COATING STD STEM SIZE 7

    MDR report key: 7619823 · Received June 20, 2018

    Report

    Report Number
    3005180920-2018-00439
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804427
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON 04 JUNE 2018 SCRATCHES ARE VISIBLE ON THE FEMORAL NECK OF THE STEM AND ON THE TRUNNION BASIS. IMAGES SHOW A FEMORAL STEM AFTER EXPLANTATION, WITH BIOLOGICAL TISSUE AND FLUIDS RESIDUALS ON THE STEM. FEMORAL HEAD SHOWS SIGNS OF METAL TRANSFER ON THE BASIS AND ON THE ARTICULATING SURFACE, PROBABLY DUE TO EXTRACTION PROCESS. INSIDE THE FEMORAL HEAD TAPER HOLE, TRUNNION METAL TRANSFER PRINT AND BLOOD RESIDUALS ARE VISIBLE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS (B)(4) ON 15 JUNE 2018 PARTIAL HIP REVISION SURGERY (STEM AND HEAD) OCCURRED 1 YEAR AND 9 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD WOMAN DUE TO PAIN. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF OSTEOLYTIC REGIONS AND REDUCED BONE DENSITY. ACCORDING TO THE REPORT, DURING REVISION SURGERY THE STEM WAS FOUND WELL FIXED. THE PICTURES OF THE HEAD DISPLAY AREAS OF SMUDGED METAL IN THE ARTICULAR ZONE: THESE MAY HAVE CONTRIBUTED TO THE CREATION OF PE DEBRIS IF THEY WERE PRESENT DURING IMPLANT SERVICE LIFE. NO INFORMATION IS AVAILABLE AS TO THE CUP IMPLANT (INSERT MATERIAL - PRESENCE OF VISIBLE WEAR). THE REASON OF THIS FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 18 JUNE 2018; LOT 161304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 APRIL 2016. EXPIRATION DATE: 2021-03-29; 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. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 20 JUNE 2018; FEMORAL HEAD SHOWS METAL TRANSFER SCRATCHES DUE TO REMOVAL PROCESS. STEM SHOWS SIGNS OF GOOD OSSEOINTEGRATION: HYDROXYAPATITE (HA) LAYER HAS BEEN ALMOST TOTALLY ABSORBED. ON THE PROXIMAL STEM SOME HA IS STILL VISIBLE. SIGNS OF STEM EXTRACTION ON THE NECK REGION. IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE OF IMPLANT FAILURE.

    Description of Event or Problem · 1

    WE WERE INFORMED ON 22 MAY 2018 THAT PATIENT FEEL PAIN IN THE HIP. THE STEM WAS LOOSE. SURGEON PLANS TO REVISED THE HIP. ADDITIONAL INFORMATION RECEIVED ON 01 JUNE 2018 BY SALES REPRESENTATIVE: THE STEM WAS LOOSE NOT SO MUCH, IT WAS NECESSARY TO USE CHISELS. SURGERY COMPLETELY SUCCESSFULLY ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463019 AMISTEM-H PROXIMAL COATING STD STEM SIZE 7 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 161304 07630030804427

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention