BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H PROXIMAL COATING STD STEM SIZE 2

    MDR report key: 7549087 · Received May 29, 2018

    Report

    Report Number
    3005180920-2018-00379
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 29, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804373
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED ON 14 MAY 2018 BY MEDICAL AFFAIRS MANAGER: FEMORAL STEM LOOSENING 8 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1, 2, 6 AND 7 AND SIGNS OF STRESS SHIELDING. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS THA AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED BATCH REVIEW PERFORMED ON 28 MAY 2018; LOT 161299: (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 ON 28 MAY 2018 BY R&D PRODUCT MANAGER: THE COATING OF THE STEM APPEARED ALMOST TOTALLY PRESENT IN THE STEM: THE PRESENCE OF THE COATING CAN INDICATE AN INCORRECT OSSEOINTEGRATION WITH THE FEMUR, ALTHOUGH SIGNS OF REGROWTH BONE WERE FOUND IN THE DISTAL PART OF THE COATING. MOREOVER, SOME SMALL SIGNS OF REMOVAL WERE FOUND IN THE TAPER AREA. FROM THE RECEIVED PIECE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    ABOUT 8 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT HIP DUE TO STEM LOOSENING. THE SURGEON SWAPPED SUCCESSFULLY THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392081 AMISTEM-H PROXIMAL COATING STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 161299 07630030804373

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention