BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED STD STEM SIZE 2

    MDR report key: 11731445 · Received April 27, 2021

    Report

    Report Number
    3005180920-2021-00347
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 27, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804274
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13.APR.2021: LOT 1901550: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-JUN-2019. EXPIRATION DATE: 2024-05-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: BIPOLAR HEAD 25060.2845 BIPOLAR HEAD Ø28X45 (K091967) LOT. 2006642. BATCH REVIEW PERFORMED ON 13.APR.2021: LOT 2006642: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-SEP-2020. EXPIRATION DATE: 2025-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT. 177463 BATCH REVIEW PERFORMED ON 13.APR.2021: LOT 177463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2018. EXPIRATION DATE: 2023-002-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628058 STEM: AMISTEM C CEMENTED STD STEM SIZE 2 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.152 1901550 07630030804274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention