BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5

    MDR report key: 7624916 · Received June 21, 2018

    Report

    Report Number
    3005180920-2018-00443
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    January 18, 2010
    Report Date
    May 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802171
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 JUNE 2018. LOT 091202: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 AUGUST 2009. EXPIRATION DATE: 2014-05-31. 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 ON 15 JUNE 2018. HIP REVISION SURGERY OCCURRED 8 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) MAN. HEAD AND CUP BELONG TO A DIFFERENT COMPANY AND NO INFORMATION IS AVAILABLE. THE QUALITY OF THE PICTURES IS VERY POOR, BUT IT SEEMS POSSIBLE THAT A LARGE HEAD METAL-ON-METAL COMBINATION WAS USED 8 YEARS AGO AND A MASSIVE DEBRIS PRODUCTION COULD BE AN EXPLANATION FOR THE RADIOPAQUE FINDING PROXIMO-LATERAL IN THE FEMUR AND FOR THE LATE LOOSENING. THE STEM LOOKS SLIGHTLY UNDERSIZED BUT IT SERVED WELL FOR MANY YEARS, SO THAT'S UNLIKELY TO BE A POTENTIAL CAUSE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 8 YEARS AND 4 MONTHS AFTER PRIMARY. INTRAOPERATIVELY THE SURGEON DETERMINED THAT THE STEM WAS LOOSE. THE SURGEON REVISED THE MEDACTA STEM, ALONG WITH THE OTHER COMPANY'S CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467186 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 091202 07630030802171

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention