BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD SIZE 1

    MDR report key: 9768289 · Received February 28, 2020

    Report

    Report Number
    3005180920-2020-00111
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    February 17, 2020
    Report Date
    February 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030801822
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12-FEB-2020: LOT 147655: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 FEBRUARY 2015. EXPIRATION DATE: 31.12.2019 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 12-FEB-2020: HIP IMPLANT: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 17472. LOT 174720: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 NOVEMBER 2017. EXPIRATION DATE: 2022-11-06 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. BATCH REVIEW PERFORMED ON 28-FEB-2020: HIP IMPLANT: CUP: VERSAFITCUP CC TRIO 01.26.45.1156 ACETABULAR SHELL CC TRIO NO-HOLE Ø 56 (K122911) LOT. 174468. LOT 174468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2017. EXPIRATION DATE: 25/10/2022. 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. THE SHELL LINER INVOLVED IN THE COMPLAINT IS NOT MARKETED IN THE USA.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO INFECTION AFTER ABOUT 2 YEARS FROM THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232211 STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD SIZE 1 HIP UNCEMENTED STEM JDI MEDACTA INTERNATIONAL SA 01.12.001 147655 07630030801822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention