BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

    MDR report key: 14574005 · Received June 2, 2022

    Report

    Report Number
    3005180920-2022-00413
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 2, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802058
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 MAY 2022 LOT 113773: (B)(4). EXPIRATION DATE: 2016-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS SPECIALIST: REVISION PERFORMED 10 YEARS AFTER THA SURGERY IN A MALE PATIENT. A PELVIS FRACTURE OCCURED DUE TO A TRAUMATIC EVENT WHICH RESULTED IN THE LOOSENING OF THE CUP. FROM THE RADIOGRAPHIC IMAGE, THE PELVIS FRACTURE IS VISIBLE. ADDITIONALLY, ACCORDING TO REPORT, DURING THE INDEX SURGERY A INTRAOPERATIVE PROXIMAL FEMORAL FRACTURE OCCURED HENCE THE CERCLAGE (VISIBLE IN THE RADIOGRAPHIC IMAGE) WAS INSERTED. NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 10 MAY 2022. CUP: VERSAFITCUP CC TRIO 01.26.45.0058 ACETABULAR SHELL CC TRIO Ø 58 (K103352) LOT. 113837 LOT 113837: (B)(4). EXPIRATION DATE: 2016-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM.TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING THE PRIMARY SURGERY, ON (B)(6) 2012, THE PATIENT SUSTAINED A PROXIMAL FEMORAL FRACTURE WHICH REQUIRED A PLATE 1-DAY POST-OP. PRESENTLY ON (B)(6) 2022, THE PATIENT HAD A FALL CAUSING A PERIPROSTHETIC FRACTURE OF THE PELVIS WHICH RESULTED IN THE LOOSENING OF THE CUP. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL HEAD AND CUP WITH A COMPETITOR DUAL MOBILITY CUP. THE STEM WAS WELL FIXED AND WAS LEFT IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438570 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4 CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.024 113773 07630030802058

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention