BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED STD STEM SIZE 3

    MDR report key: 9727247 · Received February 19, 2020

    Report

    Report Number
    3005180920-2020-00066
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804281
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 JANUARY 2020. LOT 160648: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2016. EXPIRATION DATE: 2021-02-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION: LESS THAN 2 YEARS AFTER PRIMARY HYBRID THA THE FEMORAL STEM IS FOUND LOOSE AND REPLACED. THE CAUSES FOR LOOSENING ARE UNKNOWN. THE RADIOGRAPHS SUPPLIED SHOW SEVERAL POINTS OF SEPARATION BETWEEN CEMENT AND STEM AND THE BONE HAS CAVITARY DEFECTS AND LOW DENSITY. WE DO NOT KNOW THE HISTORY OF THIS CASE AS NO FORMER RADIOGRAPHS ARE AVAILABLE, IN PARTICULAR POSTOPERATIVE IMAGES WERE NOT SUPPLIED. LOOSENING OF A CEMENTED STEM LESS THAN TWO YEARS AFTER INDEX SURGERY IS A VERY RARE OCCURRENCE BUT WE DID NOT FIND ANY CLUE TO SUGGEST THE REASON FOR THIS CASE. NO HINTS OF A DEFECTIVE DEVICE WERE FOUND IN THE INFORMATION SUPPLIED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM, AND LINER ALMOST 1 YEAR AND 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189807 STEM: AMISTEM C CEMENTED STD STEM SIZE 3 HIP CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.18.153 160648 07630030804281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention