BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.144 HA COATED LAT STEM SIZE4

    MDR report key: 8343141 · Received February 15, 2019

    Report

    Report Number
    3005180920-2019-00059
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 17, 2019
    Report Date
    February 15, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804205
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: HIP REVISION SURGERY OCCURRED 1 YEAR AND 8 MONTHS AFTER TOTAL HIP ARTHROPLASTY IN A (B)(6) MAN. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES AROUND THE STEM AND SIGNS OF STRESS SHIELDING. SCATTERED ALTERATIONS OF BONE QUALITY AND MORPHOLOGY ARE ALSO VISIBLE IN THE PROXIMAL FEMUR AND PELVIC BONES. A NEW BONE FORMATION OR BONE DETACHMENT IS VISIBLE LATERAL TO THE PROXIMAL FEMUR, ORIGIN UNKNOWN, PERHAPS IT COULD BE MORE CLEAR WITH AN ADDITIONAL VIEW. NO INFORMATION CONCERNING COMORBIDITIES AND PATIENT GENERAL HEALTH IS AVAILABLE. THE REASON OF THIS EVENT CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 11 FEBRUARY 2019: LOT 170031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2017. EXPIRATION DATE: 2022-06-07. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED THAT A PATIENT CAME IN DUE TO PAIN, 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY. AFTER XRAY EVALUATION, LUCENT LINES AND ECTOPIC BONE GROWTH WERE PRESENT. DURING REVISION PROCEDURE, PERFORMED ON (B)(6) 2019, THE STEM WAS REMOVED WITH LITTLE DIFFICULTY AND THERE WAS NO BONY IN-GROWTH PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138638 STEM: AMISTEM H 01.18.144 HA COATED LAT STEM SIZE4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 170031 07630030804205

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention