BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 6 LAT

    MDR report key: 6112620 · Received November 18, 2016

    Report

    Report Number
    3005180920-2016-00594
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2016 AND INCLUDES: THE REVISION DONE SUCCESSFULLY ON (B)(6) 2016. ALL IMPLANTS WERE EXPLANTED. PROPIONIBACTERIUM WERE FOUND. LYSIS WAS PRESENT ON THE X-RAYS BUT A TRANSFEMORAL APPROACH WAS REQUIRED - NO LOOSENING AT ALL. THE SURGEON HAD PLANNED TO REVISE THE PATIENT DUE TO INFECTION, BUT HE FOUND A CYST IN THE FEMUR DURING SURGERY. ON 04 NOVEMBER 2016, THE COMPLAINT HAS BEEN NOTIFIED TO CERAMTEC, THE MANUFACTURER OF THE CERAMIC BALL HEAD (NOT MARKETED IN THE USA) ON 11 NOVEMBER 2016, CERAMTEC PROVIDED A BATCH REVIEW OF THE INVOLVED LOT, REPORTING AS FOLLOWS: THE COMPONENT PROPERTIES AND MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION. BATCH REVIEWS PERFORMED ON 14 NOVEMBER 2016. LOT 120533: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 MAY 2012. EXPIRATION DATE: 2017-03-31. 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. VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 56, CODE 01.26.45.0056, LOT. 130565 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MARCH 2013. EXPIRATION DATE: 2018-02-28. 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. VERSAFITCUP FLAT PE HC LINER Ø 36/F, CODE 01.26.3648HCT, LOT. 132332 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 AUGUST 2013. EXPIRATION DATE: 2018-06-30. 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 18 NOVEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: LATE INFECTION AT THREE YEARS OF CEMENTLESS THA, ACCORDING TO REPORT. 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.

    Description of Event or Problem · 1

    THE SURGEON PLANNED TO REVISE THE PATIENT DUE TO INFECTION OF THE HIP PROSTHESIS. DURING SURGERY IT WAS FOUND OUT THAT THE PATIENT HAD A CYST IN THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765635 AMISTEM H, HA COATED STEM SIZE 6 LAT CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 120533

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention