BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 LAT

    MDR report key: 6126995 · Received November 24, 2016

    Report

    Report Number
    3005180920-2016-00606
    Event Type
    Injury
    Date Received
    November 24, 2016
    Date of Event
    October 24, 2016
    Report Date
    November 24, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 07 NOVEMBER 2016 AND INCLUDES: CUP, LINER AND HEAD WERE NOT MEDACTA PRODUCTS. BATCH REVIEW PERFORMED ON 21 NOVEMBER 2016. LOT 082698: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 NOVEMBER 2008. EXPIRATION DATE: 2013-09-30. 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. ON 24 NOV 2016 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: CEMENTLESS THA IN AN ELDERLY MALE PATIENT REVISED AT 7.5 YEARS. OSTEOLYTIC LESIONS ARE VISIBLE IN DIFFERENT AREAS AROUND THE STEM, POSSIBLY GENERATED BY ADVERSE REACTION TO WEAR DEBRIS. THE CUP AND LINER ARE NOT MANUFACTURED BY MEDACTA. THE STEM LOOKED WELL FIXED WITH A LIGHT RADIOLUCENT LINE IN GRUEN ZONE 1, VERY COMMON IN THIS KIND OF STEMS AFTER SEVERAL YEARS AND NORMALLY CLINICALLY SILENT. NO REASON TO SUSPECT THAT THE CAUSE FOR REVISION WAS A FAULTY FEMORAL STEM. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A CHECK-UP. THE SURGEON NOTICED OSTEOLYSIS AROUND THE STEM. THE SURGEON REVISED THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777860 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 082698

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention