BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 21771300 · Received April 4, 2025

    Report

    Report Number
    3005180920-2025-00289
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040720267
    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 MARCH 2025. LOT 2246951: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05/04/2023. EXPIRATION DATE: 15/03/2028. 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 MARCH 2025 ON LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT. 2400150. LOT 2400150: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12/03/2024. EXPIRATION DATE: 20/02/2029. 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 MARCH 2025 ON CUP: VERSAFITCUP 01.26.52MB ACETABULAR SHELL Ø 52 (K083116) LOT. 2316692 LOT 2316692: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20/02/2024. EXPIRATION DATE: 07/02/2029. 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 MARCH 2025 ON BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 2412375. LOT 2412375: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21/05/2024. EXPIRATION DATE: 02/05/2029. 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. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323324 AMISTEM-P COLLARED STEM: AMISTEM-P COLLARED STD STEM SIZE 7 LPH MEDACTA INTERNATIONAL SA 01.18.437 2246951 07630040720267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention