BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-P STD STEM SIZE 2

    MDR report key: 9799722 · Received March 6, 2020

    Report

    Report Number
    3005180920-2020-00132
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 6, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720434
    PMA / PMN Number
    K181254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 FEBRUARY 2020. LOT 1902365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2019. EXPIRATION DATE: 2024-06-24. 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 PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FEMORAL FRACTURE. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURES. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE. THE SURGEON PUT CABLES AROUND THE FEMUR TO SECURE THE FRACTURE AND REVISED THE HEAD 28 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266078 STEM: QUADRA-P STD STEM SIZE 2 HIP IMPLANT: CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1902365 07630040720434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention