BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, COLLARED HA COATED STEM SIZE 5 STD

    MDR report key: 6515525 · Received April 24, 2017

    Report

    Report Number
    3005180920-2017-00204
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 24, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 24 APRIL 2017. LOT 156255: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 FEBRUARY 2016. EXPIRATION DATE: 2021-02-06. 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. COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5, CODE 01.25.011, LOT. 162045 (K072857), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 APRIL 2016. EXPIRATION DATE: 2021-04-12. 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. BIPOLAR HEAD Ø28X47, CODE 25060.2847, LOT. 151033 (K091967), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JUNE 2015. EXPIRATION DATE: 2020-04-30. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297377 AMISTEM H, COLLARED HA COATED STEM SIZE 5 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 156255

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention