BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 5

    MDR report key: 19790170 · Received July 22, 2024

    Report

    Report Number
    3005180920-2024-00539
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 12, 2024
    Report Date
    February 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030801860
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERAMIC SUPPLIER ON (B)(6) 2025: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. VISUAL INSPECTION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGERS: FEMORAL COMPONENTS. LOOKING AT THE EXPLANTED STEM BODY SOME SIGNS OF MINOR DAMAGE AND SCRATCHES ARE PRESENT ON BOH THE NECK AND THE BODY OF THE EXPLANTED STEM, WHICH IS LIKELY DUE TO THE REVISION SURGERY AND NOT RELEVANT TO THE REPORTED ISSUE. THE ROOT CAUSE OF IMPLANT FAILURE IS UNKNOWN. ACETABULAR COMPONENTS: A VISIBLE DIRT PART TISSUE, MAYBE INFECTED TISSUE, WAS NOTICED BETWEEN THE LINER AND CUP. FROM THE RECEIVED PARTS IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. ADDITIONAL COMPONENTS INVOLVED (FROM COMPETITORS): IMPLANTS FROM CERAMTEC 38.49.7179.275.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 LOT. 640710. IMPLANTS FROM CERAMTEC 38.49.7188.545.20 CERAMIC LINER Ø 36 / E LOT. 640064. PARTS MODIFIED/ADDED: B5, D9 AND H3, VISUAL INSPECTION, SUPPLIER ANALYSIS (DOCUMENT REVIEW).

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 1 JULY 2024. LOT 100299: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2010. EXPIRATION DATE: 2015-15-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT REVISED. BATCH REVIEW PERFORMED ON 1 JULY 2024 ON CUP: VERSAFITCUP CC TRIO 01.26.56MBT ACETABULAR SHELL CC Ø 56 () LOT. 100344. LOT 100344: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2010. EXPIRATION DATE: 2015-30-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. DEVICE NOT MARKETED IN US.

    Description of Event or Problem · 0

    REVISION SURGERY FOR HIP INFECTION ON (B)(6) 2024, DATE OF PRIMARY IS UNKNOWN BUT IT WAS IN 2010. ALL DEVICES REVISED SUCCESSFULLY.

    Description of Event or Problem · 0

    REVISION SURGERY FOR HIP INFECTION ON THE (B)(6) 2024, DATE OF PRIMARY IS UNKNOWN. ALL DEVICES REVISED SUCCESSFULLY. HEAD AND LINER REFERENCES AND LOT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979707 STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 5 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 100299 07630030801860

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Required Intervention