BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3

    MDR report key: 19790171 · Received July 22, 2024

    Report

    Report Number
    3005180920-2024-00522
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720120
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27-JUN-2024. LOT 2214524: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2022. EXPIRATION DATE: 2027-10-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: LATE INFECTION IN CEMENTLESS THA, 1.3 YEARS 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. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 27-JUN-2024. LINER: MECTACER 01.29.414 CERAMIC LINER Ø 36 / F (NOT DISTRIBUTED IN US) LOT. 2217263 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2022. EXPIRATION DATE: 2027-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2247815: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2023. EXPIRATION DATE: 2027-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56 (K103352) LOT 2240318: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2023. EXPIRATION DATE: 2027-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 3 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION WHICH CAUSED STEM LOOSENING. NO MOBILIZATION OF THE ACETABULAR SHELL HAS BEEN DETECTED. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS AND IMPLANTED A M-VIZION STEM WITH VERSAFITCUP DM COMPONENTS AND CERAMIC BALL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979708 STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3 HIP FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 2214524 07630040720120

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention