BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK

    MDR report key: 9493949 · Received December 19, 2019

    Report

    Report Number
    3005180920-2019-01074
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    December 5, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802614
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 NOVEMBER 2019: LOT 090847: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2009. EXPIRATION DATE: 2014-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD, WITHOUT ANY SIMILAR EVENT REPORTED. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL DIRECTOR: HIP REVISION SURGERY PERFORMED 10 MONTHS AFTER CEMENTLESS PRIMARY TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, ACTIVITY LEVEL AND COMORBIDITIES IS AVAILABLE NOR IMMEDIATE POSTOPERATIVE IMAGES. THE PRE-REVISION XRAY SHOWS A CLEARLY UNDERSIZED STEM THAT SUBSIDED. AN ESTIMATION OF UNDERSIZING BASED ON ONE PROJECTION IS VERY UNRELIABLE, SO IT MUST BE TAKEN AS ESTIMATION ONLY. THE ACETABULAR CUP IS SHOWN TO BE TOO VERTICAL, AND AGAIN WE DO NOT KNOW IF THAT IS THE RESULT OF MIGRATION OR IT WAS THE ORIGINAL PLACEMENT AND IN THIS CASE, FOR WHAT REASON THIS POSITION WAS CHOSEN. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE LIMITED INFORMATION AT HAND. PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: IMPLANTS ARE COVERED IN BIOLOGICAL FLUIDS. IT IS NOT POSSIBLE TO DETERMINE ANY POSSIBLE FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 10 MONTHS AFTER PRIMARY SURGERY, DUE TO PAIN. STEM HAS BEEN SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287159 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK UNCEMENTED HIP STEM JDI MEDACTA INTERNATIONAL SA 090847 07630030802614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention