BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE1

    MDR report key: 11784064 · Received May 6, 2021

    Report

    Report Number
    3005180920-2021-00353
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 6, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802027
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 APRIL 2021: LOT 073152: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2008. EXPIRATION DATE: 2012-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: HIP REVISION SURGERY PERFORMED 13 YEARS AFTER CEMENTLESS DOUBLE-MOBILITY TOTAL HIP ARTHROPLASTY. THE PRE-REVISION XRAYS SHOW A PROXIMAL FEMUR SIGNIFICANTLY OSTEOPOROTIC BUT THIS MAY BE THE RESULT OF OSTEOLYTIC ACTIVITY THAT COULD HAVE BEEN TRIGGERED BY POLYETHYLENE WEAR OVER THE THIRTEEN YEARS OF ACTIVE SERVICE OF THIS IMPLANT. 10 YEARS OF ACTIVE SERVICE CORRESPONDS TO WHAT MANY LITERATURE ARTICLES DESCRIBE AS THE LIFE EXPECTANCY OF A STANDARD PE INSERT. ANALYSIS OF THE EXPLANTED LINER COULD INDICATE IF ABNORMAL WEAR TOOK PLACE. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 06.05.2021: LINER: VERSAFITCUP DM 01.26.2850M DOUBLE MOBILITY LINER Ø 50/28 (K083116), LOT 080524: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APR-2008. EXPIRATION DATE: 2013-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT SINCE 2017.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 12 YEARS 10 MONTHS AFTER THE PRIMARY. STEM, HEAD, AND LINER SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681800 STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE1 FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 01.12.021 073152 07630030802027

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention