BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED STD STEM SIZE 4

    MDR report key: 9961666 · Received April 15, 2020

    Report

    Report Number
    3005180920-2020-00240
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 16, 2020
    Report Date
    April 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804298
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT WEIGHT HAS NOT BEEN REPORTED, THE ONLY INFORMATION AVAILABLE IS THAT IT IS LESS THAN 100 KG. BATCH REVIEW PERFORMED ON 26 MARCH 2020: LOT 1907518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2020. EXPIRATION DATE: 2025-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.013 COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K072857) LOT. 1900775. BATCH REVIEW PERFORMED ON 26 MARCH 2020: LOT 1900775: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2019. EXPIRATION DATE: 2024-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28 (K092265) LOT. 1903332. BATCH REVIEW PERFORMED ON 26 MARCH 2020: LOT 1903332: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2019. EXPIRATION DATE: 2025-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER. IMPLANT COVERED IN BIOLOGICAL FLUIDS. IT IS NOT POSSIBLE TO DETERMINE AN IMPLANT RELATED FAILURE ROOT CAUSE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: EARLY INFECTION IN HYBRID THA, FEW WEEKS 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.

    Description of Event or Problem · 1

    1 MONTH AFTER PRIMARY SURGERY, REVISION SURGERY FOR INFECTION. THE STEM, THE HEAD AND THE DOUBLE MOBILE LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424585 STEM: AMISTEM C CEMENTED STD STEM SIZE 4 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.154 1907518 07630030804298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention