BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P

    MDR report key: 21771298 · Received April 4, 2025

    Report

    Report Number
    3005180920-2025-00278
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040720014
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 MAR 2025. LOT 188731: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 2024-02-14. 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. ADDITIONAL IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 21 MAR 2025 ON BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT. 1811842. LOT 1811842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2019. EXPIRATION DATE: 2024-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 21 MAR 2025 ON CUP: MPACT 01.32.156DH ACETABULAR SHELL Ø56 TWO-HOLES (K132879) LOT. 1810288. LOT 1810288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2019. EXPIRATION DATE: 2024-03-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 21 MAR 2025 ON LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT. 1811218. LOT 1811218: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2019. EXPIRATION DATE: 2024-03-03. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT 5 YEARS 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323322 AMISTEM-P STEM: AMISTEM-P STD STEM SIZE 2 LPH MEDACTA INTERNATIONAL SA 01.18.402 188731 07630040720014

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention