BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 2 STD

    MDR report key: 5991575 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00502
    Event Type
    Injury
    Date Received
    September 30, 2016
    Report Date
    December 29, 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 ON (B)(6) 2016 AND INCLUDES: THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2016. STEM AND LINER WERE REVISED. DURING PRIMARY SURGERY, AN INTRAOPERATIVE FRACTURE OF THE GREATER TROCHANTER OCCURRED AND IT WAS RESOLVED DURING THE SAME SURGERY. A STEM ROTATION OCCURRED DURING POSTOPERATIVE REHABILITATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 AND INCLUDES: THE STEM MOVED FROM ITS POSITION IN THE REHABILITATION PERIOD STARING IN THE WRONG POSITION. ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEMORAL LOOSENING IN CEMENTLESS THA AFTER 6 YEARS. THE LOAD TRANSFER PATTERN OF THIS PATIENT IS CERTAINLY WRONG, BUT THE REASONS ARE DIFFICULT TO UNDERSTAND. THE REVISED STEM MUST BE THE RIGHT SIDE, BUT THE LEFT IS SHOWING SIGNS OF ALTERED STRESS PATTERNS TOO, IN SPITE OF THE SMALLER SIZE OF STEM USED. IN BOTH CASES, IMPLANTATION TECHNIQUE APPEARS CORRECT AND WELL EXECUTED. ASEPTIC LOOSENING IS A POSSIBLE ADVERSE EVENT FOLLOWING THA AND SOMETIMES THE REASONS FOR THE LOOSENING CANNOT BE DETERMINED. ON (B)(6) 2016 MEDACTA BECAME AWARE THAT THE FOLLOWING INFORMATION WERE WRONGLY REPORTED IN THE INITIAL REPORT: SUSPECT MEDICAL DEVICE DETAILS (BRAND NAME, COMMON DEVICE NAME, EXPIRATION DATE, DEVICE MANUFACTURE DATE AND IMPLANTED DATE). THE CASE HAS BEEN UPDATED TO INCLUDE THE CORRECT INFORMATION. BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 103211: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 NOVEMBER 2010. EXPIRATION DATE: 2015-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2016. LOT 092582: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 DECEMBER 2009. EXPIRATION DATE: 2014-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED ON (B)(6) 2016 DUE TO STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643883 AMISTEM H, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 103211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention