BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3

    MDR report key: 9822777 · Received March 12, 2020

    Report

    Report Number
    3005180920-2020-00140
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    February 12, 2020
    Report Date
    March 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802157
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 FEBRUARY 2020: LOT 152983: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SET-2015. EXPIRATION DATE: 2020-09-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED SINCE 2016. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTLESS THA, 1 MONTH AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL ITEMS INVOVLED IN THE EVENT, BATCH REVIEW PERFORMED ON 21 FEBRUARY 2020: CUP: VERSAFITCUP CC TRIO 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø 52 (K103352) LOT. 1903297. LOT 1903297: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2019. EXPIRATION DATE: 2024-06-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED. LINER: CC E CC LIGHT 01.26.3644HCT FLAT PE HC LINER Ø 36 / E (K103352) LOT. 1904384. LOT 1904384: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUNE-2019. EXPIRATION DATE: 2024-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 1903858. LOT 1903858: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JULY-2019. EXPIRATION DATE: 2024-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO AN INFECTION. THE HEAD, STEM AND INLAY WERE REVISED AND THE PATHOGEN KIND IS UNKNOWN. THE STEM WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286071 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3 CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.033 152983 07630030802157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention