BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 15860095 · Received November 24, 2022

    Report

    Report Number
    3005180920-2022-00881
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    November 3, 2022
    Report Date
    November 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 NOVEMBER 2022, LOT: 144465: (B)(4) MANUFACTURED AND RELEASED ON 12-SEP-2014. EXPIRATION DATE: 2019-07-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: SECOND REVISION LESS THAN 2 YEARS AFTER THE PREVIOUS REVISION SURGERY WHEN THE CEMENTED STEM HAD BEEN IMPLANTED IN EXCHANGE OF A CEMENTED LOOSE STEM. IN THE SECOND REVISION, THE SURGEON REVISED ALL THE COMPONENTS AND IMPLANTED M-VIZION STEM AND VERSAFITCUP DM. ACCORDING TO REPORT, THE SURGEON HAD TO FRACTURE VOLUTARILY THE FEMUR DUE TO A FALSE ROUTE AND THE MORPHOLOGY OF THE PATIENT AND HE PUT CERCLAGE TO STABILIZE EVERYTHING. FROM THE PRE-REVISION IMAGES, RADIOLUCENT LINES IN GRUEN ZONES 1 AND 7 AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 21-NOV-2022, STEM: AMISTEM C 01.18.152 CEMENTED STD STEM SIZE 2 (K103189) LOT: 2002906 LOT: 2002906: (B)(4) MANUFACTURED AND RELEASED ON 03-JULY-2020. EXPIRATION DATE: 2025-06-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM.TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP CC TRIO 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø 52 (K103352) LOT: 143432 LOT: 143432: (B)(4) MANUFACTURED AND RELEASED ON 31-JULY-2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2014. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO A LOOSE STEM. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND STEM. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO STEM AND CUP LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL THE COMPONENTS AND IMPLANTED M-VIZION STEM AND VERSAFITCUP DM. THERE WAS A FALSE ROUTE AND THE MORPHOLOGY OF THE PATIENT FORCED THE SURGEON TO FRACTURE THE FEMUR VOLUNTARILY AND PUT CERCLAGE TO STABILIZE EVERYTHING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918848 STEM: AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.132 144465 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention