BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3

    MDR report key: 14571958 · Received June 2, 2022

    Report

    Report Number
    3005180920-2022-00417
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802041
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MAY 2022. LOT 072771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2008. EXPIRATION DATE: 2012-10-31. 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 2013. ADDITIONAL COMPONENT INVOLVED: LINER: CC E CC LIGHT 01.26.3244STT FLAT PE LINER Ø 32 / E (K103352) LOT 072321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2007. EXPIRATION DATE: 2012-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2013. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT ABOUT 14 YEARS AFTER PRIMARY CEMENTLESS THA THE PE INSERT IS WORN AND THE STEM LOOSENED, WITH A VISIBLE PRESENCE OF OSTEOLYSIS THAT MAY HAVE BEEN INDUCED AS A REACTION TO WEAR DEBRIS. GENDER, AGE, AND ACTIVITY OF THE PATIENT WERE NOT REPORTED. A STANDARD PE INLAY HAD BEEN CHOSEN AT PRIMARY SURGERY. THE PRESENCE OF WEAR AFTER 14 YEARS IN A STANDARD PE INLAY IS RATHER NORMAL AND DESCRIBED IN THE LITERATURE; IN THIS CASE, THE INSERT WAS NOT COMPLETELY WORN OUT BUT THE OSTEOLYTIC REACTION MADE THE REVISION NECESSARY. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGERS FROM THE INSPECTION OF THE LINER, SIGNS OF REMOVAL WERE PRESENT. THE SIGNS ARE RELATED TO THE EXTRACTION OF THE LINER, BOTH THE WORN WALL AND THE HOLE, CAUSED BY USING THE EXTRACTION SCREW. FROM THE RECEIVED PARTS IT WAS DIFFICULT TO EVALUATE THE SIGNS RELATED TO A POTENTIAL WEAR AND IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT. REGARDING THE STEM IT IS EVALUATED THAT WHOLE HA COATING ON THE STEM BODY HAS BEEN COMPLETELY ABSORBED BY PATIENT BONE AS EXECUTED. SOME SIGNS AND SCRATCHES WITH BURNS ARE PRESENT ON THE NECK SURFACE, PROBABLY DUE TO REVISION SURGERY. A POSSIBLE ROOT CAUSE OF THE STEM LOOSENING SHOULD BE THE OSTEOLYSIS DUE TO THE PE LINER WEAR AS REPORTED.

    Description of Event or Problem · 0

    REVISION SURGERY FOLLOWING SUSPECTED LINER WEAR AND STEM LOOSENING 14 YEARS AND 4 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154777 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3 HIP STEM CEMENTLESS JDI MEDACTA INTERNATIONAL SA 01.12.023 072771 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention