BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 5

    MDR report key: 14373283 · Received May 12, 2022

    Report

    Report Number
    3005180920-2022-00355
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804212
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 APRIL 2022: LOT 152132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2015. EXPIRATION DATE: 2020-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS SPECIALIST. AT 6 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM IS NO LONGER WELL FIXED PROXIMALLY AND THE PATIENT FEELS PAIN. THE REPORT MENTIONS OSTEOLYSIS BUT THE QUALITY OF THE IMAGES PROVIDED DOES NOT ALLOW TO CONFIRM THIS FINDING. ASEPTIC LOOSENING AT MEDIUM TERM IS A POSSIBLE ADVERSE EVENT FOLLOWING THA DESCRIBED IN LITERATURE. NO DEFINITE CONCLUSION CAN BE DEFINED WITH THE INFORMATION AT HAND. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. LOOKING AT THE IMAGES ATTACHED TO THIS COMPLAINT IT IS VISIBLE THAT ALL HA ON THE STEM BODY HAS BEEN ABSORBED BY PATIENT BONE. THERE ARE HUGE RESIDUALS OF PATIENT BLOODS ON THE STEM BODY AND NECK PARTS. SOME SIGNS AND SCRATCHES ARE VISIBLE ON THE NECK SURFACE PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED EXPLANTATION.

    Description of Event or Problem · 0

    REVISION SURGERY AT 6 YEARS AND 5 MONTHS POST PRIMARY FOR FEMUR OSTEOLYSIS. THE SURGEON REVISED SUCCESSFULLY THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2383051 STEM: AMISTEM H HA COATED LAT STEM SIZE 5 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.145 152132 07630030804212

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention