BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C FEMORAL STEMS

    MDR report key: 20877888 · Received December 9, 2024

    Report

    Report Number
    3005180920-2024-01061
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    November 20, 2024
    Report Date
    December 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030804274
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 DECEMBER 2024. LOT 2012819: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-FEB-2021. EXPIRATION DATE: 2026-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED: BALL HEADS: MECTACER 01.29.205 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-M (K112115) LOT. 2109338 BATCH REVIEW PERFORMED ON 02 DECEMBER 2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 188505 BATCH REVIEW PERFORMED ON 02 DECEMBER 2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2018. EXPIRATION DATE: 2023-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133620 AMISTEM C FEMORAL STEMS AMISTEM-C STD. SIZE 2 JDI MEDACTA INTERNATIONAL SA 01.18.152 2012819 07630030804274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention