BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 3

    MDR report key: 8436673 · Received March 20, 2019

    Report

    Report Number
    3005180920-2019-00169
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 19, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803192
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MARCH 2019: LOT 180803: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2018. EXPIRATION DATE: 2023-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD, WITHOUT ANY ANOTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEMORAL COMPONENT REVISION OCCURRED 6 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN AFFECTED BY METABOLIC BONE DISEASE. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF A SUBSIDED STEM, PROBABLY UNDERSIZED AND SLIGHTLY VARUS, AND PERHAPS AFFECTED BY A MALROTATION. THE REASON FOR THIS POSITION CANNOT BE ASSESSED ON THE BASIS OF A SINGLE ANTEROPOSTERIOR POSTOPERATIVE X-RAY. PATIENT ANATOMY OR BONE MORPHOLOGY MAY BE ONE REASON. WE CANNOT DETERMINE WHETHER THE CAUSE OF THE SUBSIDENCE WAS THE INITIAL POSITION OR THE METABOLIC BONE DISEASE THAT PREVENTED SECONDARY FIXATION OF THE IMPLANT, BUT THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN REVISED (USING QUADRA H STEM) 6 MONTHS AFTER PRIMARY SURGERY DUE TO PAIN AND STEM LOOSENING (THE STEM HAS SUBSIDED), INITIALLY THE STEM WAS PLACED IN VARUS POSITION AND PROBABLY UNDERSIZED. CONTRIBUTING FACTORS MAY ALSO BE RELATED TO METABOLIC BONE DISORDER THAT THE PATIENT HAS SUFFERED FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231079 STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 180803 07630030803192

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention