BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 9652061 · Received January 31, 2020

    Report

    Report Number
    3005180920-2020-00012
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    January 3, 2020
    Report Date
    January 31, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JANUARY 2020: LOT 176507: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2018. EXPIRATION DATE: 2023-02-02. 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 1-1-2016. ADDITIONAL IMPLANT INVOLVED: LINER: CC E CC LIGHT 01.26.3244HCT FLAT PE HC LINER Ø 32 / E (K103352) LOT. 177506. BATCH REVIEW PERFORMED ON 15 JANUARY 2020: LOT 177506: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2018. EXPIRATION DATE: 2023-02-04. 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 1-1-2016. ADDITIONAL IMPLANT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 (K103352) LOT. 177478. BATCH REVIEW PERFORMED ON 15 JANUARY 2020: LOT 177478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2018. EXPIRATION DATE: 2023-02-15. 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 1-1-2016. ADDITIONAL IMPLANT INVOLVED: OTHER: SCREWS 01.26.65.25 CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 25 (K103352) LOT. 179026. BATCH REVIEW PERFORMED ON 15 JANUARY 2020: LOT 179026: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2018. EXPIRATION DATE: 2023-01-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR EVENT REPORTED SINCE 1-1-2016. ADDITIONAL IMPLANT INVOLVED: IMPLANTS FROM CERAMTEC 38.49.7175.685.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 LOT. 7011126718. MANUFACTURING PROCESS REVIEW: THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFILL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. CLINICAL EVALUATION PERFORMED BY MEDICLA AFFAIRS MANAGER DELAYED INFECTION IN CEMENTLESS THA, 20 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER FEMORAL STEM, AND ACETABULAR CUP WITH SIGN OF OSSEOINTEGRATION. ON ALL COMPONENTS SIGNS OF IMPLANT REVISION. FORM VISUAL INVESTIGATION IT IS NOT POSSIBLE TO DETERMINE FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    REVISION SURGERY ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY FOR INFECTION. THE SURGEON REVISED SUCCESSFULLY THE PATIENT HIP DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117824 STEM: AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.132 176507 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention