BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 4 12/14

    MDR report key: 10307068 · Received July 22, 2020

    Report

    Report Number
    3005180920-2020-00433
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802256
    PMA / PMN Number
    K083558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 JUNE 2020 LOT 182703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-07-03. 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 1.5 YEARS AFTER PRIMARY HYBRID THA THE CEMENT MANTLE SUBSIDED AND DETACHED FROM THE BONE, MAKING THE FEMORAL CONSTRUCT UNSTABLE. THE SEPARATION BETWEEN CEMENT AND BONE IS CLEARLY VISIBLE IN THE XRAYS SUPPLIED. NO DATE IS VISIBLE, SO WE CAN'T TELL IF THIS HAPPENED SECONDARILY OR WAS A CEMENT/CEMENTATION PROBLEM IN THE IMMEDIATE POSTOPERATIVE. NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO STEM SUBSIDENCE 1 YEAR AND 6 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772917 STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 4 12/14 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.12.044 182703 07630030802256

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention