BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 3 12/14

    MDR report key: 9848075 · Received March 18, 2020

    Report

    Report Number
    3005180920-2020-00162
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802249
    PMA / PMN Number
    K083558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28-FEB-2020: LOT 155701: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7 DECEMBER 2015. EXPIRATION DATE: 2020-11-23. 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. CLINICAL EVALUATION PERFORMED BY CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR HIP REVISION PERFORMED 3,5 YEARS AFTER HYBRID TOTAL HIP ARTHROPLASTY IN A HEAVY ((B)(6) KG) (B)(6) YEAR OLD PATIENT. NO INFORMATION CONCERNING PATIENT GENERAL HEATH STATUS AND COMORBIDITIES IS AVAILABLE. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF SIGNS OF STRESS SHIELDING.

    Description of Event or Problem · 1

    HIP REVISION AFTER 3 YEARS AND 7 MONTHS FROM THE PRIMARY DUE TO STEM LOOSENING AND INFECTION SUSPICIOUS. ALL IMPLANTS WERE REVISED, NO INFECTION PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311488 STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 3 12/14 HIP CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.12.043 155701 07630030802249

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention