BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK

    MDR report key: 9238207 · Received October 25, 2019

    Report

    Report Number
    3005180920-2019-00899
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    September 26, 2019
    Report Date
    October 24, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2019: LOT 150995: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. INTRAOPERATIVE BREACH OF THE FEMORAL CANAL, IN A CASE THAT WAS PROBABLY A PROXIMAL FEMORAL FRACTURE OR FRACTURE OF FEMORAL NECK. THE FACT THAT THE BREACH WAS NOT DETECTED INTRAOPERATIVELY IS RATHER UNUSUAL; THIS LED TO CLOSE THE WOUND AND THE PATIENT NEEDED REOPERATION. THE CAUSE OF THIS ADVERSE EVENT DOES NOT LIE IN ANY DEFECTIVE COMPONENT.

    Description of Event or Problem · 1

    AFTER THE PRIMARY HIP SURGERY ON (B)(6) 2019, THE PATIENT WAS IN RECOVERY, AND HAD A POST-OP X-RAYS TAKEN THAT SHOWED THAT THE STEM HAD BREACHED THE MEDIAL ASPECT OF THE FEMORAL CANAL AT THE LEVEL OF THE LESSER TROCHANTER, AND WAS NOT SITTING INTO THE FEMORAL CANAL AS NEEDED. ON (B)(6) 2019 (2 DAYS AFTER PRIMARY), THE SURGEON REVISED THE STEM IMPLANT AND BROACHED THE CANAL AGAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032172 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 150995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention