BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM P STD STEM SIZE 8

    MDR report key: 17641503 · Received August 29, 2023

    Report

    Report Number
    3005180920-2023-00653
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 29, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720076
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 2238585: 20 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2023. EXPIRATION DATE: 2027-12-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2023. MASTERLOC 01.39.210 CEMENTLESS TI COATED LAT STEM SIZE 10 (K151531) LOT 2213489: 20 ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2022. EXPIRATION DATE: 2027-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFOMRED BY MEDACTA MEDICAL AFFAIRS MANAGER: REVISION SURGERY ON THE SAME DAY OF THE PRIMARY DUE TO FEMORAL BONE FRACTURE ON A OVERWEIGHT PATIENT. AFTER THE PRIMARY, THE SURGEON DECIDED TO CHANGE THE STEM FROM AMISTEM P SIZE 6 TO AMISTEM-P SIZE 8. A FRACTURE WAS SOON DETECTED, THE AMISTEM-P WAS REMOVED AND IT WAS IMPLANTED A MASTERLOC WITH CERCLAGE FOR THE FRACTURE AS IT IS VISIBLE FROM THE RADIOGRAPHIC IMAGES. UNFORTUNATELY, 3 WEEKS AFTER, THE PATIENT PUT WEIGHT ON THE OPERATED LEG AND ANOTHER FRACTURE OCCURED. THE BONE WAS WEAKENED BY THE OPERATION AND DUE TO THE WEIGHT OF THE PATIENT IT FRACTURED. A SECOND REVISION WAS UNDERTAKEN AND M-VIZION WITH CERCLAGE WAS IMPLANTED. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON THE SAME DAY OF THE PRIMARY DUE TO FEMORAL BONE FRACTURE. AMISTEM-P REMOVED, FRACTURE CABLED AND MASTERLOC IMPLANTED. THREE WEEKS AFTER, THE BONE FRACTURED AGAIN, PROBABLY BECAUSE THE PATIENT FULLY LOAD THE JOINT A FEW DAYS AFTER SURGERY. M-VIZION IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173609 AMISTEM P STD STEM SIZE 8 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2238585 07630040720076

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention