BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6

    MDR report key: 12891360 · Received November 30, 2021

    Report

    Report Number
    3005180920-2021-00943
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 30, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802188
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 NOVEMBER 2021. LOT 04-1683: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2005. EXPIRATION DATE: 2009-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 15 YEARS AFTER PRIMARY CEMENTLESS THA, A TRAUMA CAUSES PELVIC FRACTURE AND CONSEQUENT MOBILIZATION OF THE ACETABULAR CUP. DURING REVISION SURGERY, THE STEM IS DEEMED LOOSE TOO AND REPLACED. NO REASON TO SUSPECT A FAULTY DEVICE AS THE ROOT CAUSE FOR THIS ADVERSE EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 11 NOVEMBER 2021: CUP: VERSAFITCUP CC 01.26.50MBT ACETABULAR SHELL CC Ø 50 LOT. 060775 (THE ITEM IS NOT REGISTERED IN USA). LOT 060775: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2006. EXPIRATION DATE: 2011-MAY-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 0

    THE LOOSENING OF THE CUP WAS NOTICED IN A CONTROL X-RAY, THE LOOSENING OF THE STEM WAS NOTICED DURING SURGERY. LOOSENING WAS MAYBE DUE TO A TRAUMA OF THE PATIENT. REVISION SURGERY WAS PERFORMED 15 YEARS AND 2 MONTHS AFTER PRIMARY, ALL IMPLANTS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792365 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.12.036 04-1683 07630030802188

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention