BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1

    MDR report key: 11568315 · Received March 25, 2021

    Report

    Report Number
    3005180920-2021-00235
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802133
    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 04 MARCH 2021: LOT 072273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2007. EXPIRATION DATE: 2012-09-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) ITEMS HAS BEEN RE-STERILIZED AS LOT 072273/T AND RELEASED ON 07-NOV-2013. EXPIRATION DATE: 2018-09-31. 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 SINCE 1-1-2017. CLINICAL EVALUATION: STEM REVISION PERFORMED 4 YEARS AND 8 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN. IN THE RADIOGRAPHIC IMAGE PROVIDED, SIGNS OF STRESS SHIELDING ARE VISIBLE AND THE STEM LOOKS SLIGHTLY UNDERSIZED. THE REASON OF THIS CHOICE CANNOT BE ASSESSED ON THE BASIS OF A SINGLE ANTEROPOSTERIOR RADIOGRAPHIC PROJECTION. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. PRELIMINARY INVESTIGATION: LOOKING AT THE IMAGES OF THE EXPLANTED STEM IT IS VISIBLE THAT ALMOST ALL HA COATING ON THE STEM BODY HAS BEEN ABSORBED BY PATIENT BONE AS EXPECTED. THERE ARE ONLY A FEW RESIDUAL FRAGMENTS OF HA COATING ON THE BODY. THE ROOT CAUSE REMAINS UNKNOWN.

    Description of Event or Problem · 1

    4 YEARS AND 8 MONTHS AFTER PRIMARY, REVISION SURGERY FOR LOOSE QUADRA H STEM. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464871 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1 CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.031 072273/T 07630030802133

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention