BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 3

    MDR report key: 17412680 · Received July 28, 2023

    Report

    Report Number
    3005180920-2023-00608
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-JUL-2023: LOT 152248: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2015. EXPIRATION DATE: 2020-07-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT CAME IN REPORTING PAIN DUE TO EXPERIENCING MULTIPLE DISLOCATIONS. THE SURGEON REPLACED SUCCESSFULLY THE CUP, HEAD AND LINER. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919891 STEM: AMISTEM H HA COATED STD STEM SIZE 3 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 152248 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention