BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14

    MDR report key: 8436664 · Received March 20, 2019

    Report

    Report Number
    3005180920-2019-00165
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 19, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802225
    PMA / PMN Number
    K083558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: HIP REVISION SURGERY OCCURRED 4 YEARS AND 8 MONTHS AFTER IMPLANTATION OF A HYBRID DOUBLE-MOBILITY TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, BMI AND GENERAL HEALTH STATUS IS AVAILABLE. BOTH FEMORAL (CEMENTED) AND ACETABULAR (CEMENTLESS) COMPONENTS WERE FOUND TO BE LOOSE, A RATHER UNUSUAL SITUATION. BASED ON THE INFORMATION AVAILABLE, NO FINAL CONCLUSION CAN BE DRAWN. BATCH REVIEW PERFORMED ON 18 MARCH 2019: LOT 111149: 40 ITEMS MANUFACTURED AND RELEASED ON 29-APR-2011. EXPIRATION DATE: 2016-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED IN LOOSENING: CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL CC Ø 50 (K083116) LOT 135596: 60 ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO CAME IN COMPLAINING OF PAIN 4 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO AN ASEPTIC LOOSENING OF THE STEM AND A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. ON THE FOLLOWING DAY, THE SURGEON REVISED THE CUP, LINER, HEAD AND STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230872 STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 1 12/14 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 111149 07630030802225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention