BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 00

    MDR report key: 7446633 · Received April 20, 2018

    Report

    Report Number
    3005180920-2018-00258
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    March 21, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803765
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 24 MAY 2018: FEMORAL STEM SHOWS DEEP SCRATCHES ON THE NECK REGION AND ON THE DISTAL PART DUE TO THE DIFFICULT EXTRACTION PROCESS. THESE ARE IN LINE WITH THE CLINICAL SITUATION, WITH LOOSENING OF THE PROXIMAL STEM AND BONE FIXATION ON CENTRAL AND DISTAL STEM. SIGNS OF BONE ARE STILL VISIBLE ON THE STEM. HYDROXYAPATITE LAYER HAS BEEN ABSORBED DURING IN SITU TIME. IT IS NOT POSSIBLE TO DEFINE THE LOOSENING ROOT CAUSE FROM THE IMPLANT ANALYSIS.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 APRIL 2018. LOT 133051: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 SEPTEMBER 2013. EXPIRATION DATE: 2018-08-31. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 20 APRIL 2018 REVISION OF PRIMARY CEMENTLESS THA IN A YOUNG FEMALE PATIENT. AFTER 2 YEARS, DISTALIZATION OF FIXATION DEVELOPED AND RESULTED IN LOSS OF MECHANICAL STABILITY, WHICH REQUIRED CHANGE OF THE STEM. NO INFECTION WAS DETECTED. LOSS OF CEMENTLESS FIXATION IS A KNOWN, POSSIBLE ADVERSE EVENT FOLLOWING THA. IN THIS CASE, WE HAVE NO REASON TO SUSPECT A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO PAIN. THE STEM WAS FIXED DISTALLY AND MOBILIZED PROXIMALLY (STEM POTTED) AFTER ABOUT 4 YEARS FROM PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289366 AMISTEM H HA COATED STD STEM SIZE 00 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 133051 07630030803765

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention