BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 5 STD

    MDR report key: 6349047 · Received February 22, 2017

    Report

    Report Number
    3005180920-2017-00051
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    January 21, 2017
    Report Date
    February 22, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 02 FEBRUARY 2017 AND INCLUDES: PATHOGEN RESULTS ARE NOT AVAILABLE. BATCH REVIEWS PERFORMED ON 20 FEBRUARY 2017. LOT 163837: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 SEPTEMBER 2016. EXPIRATION DATE: 2021-09-01. 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 M 0, CODE 01.25.012, LOT. 151903 (K072857), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 JULY 2015. EXPIRATION DATE: 2020-05-31. 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 Ø28X52, CODE 25060.2852, LOT. 131481 (K091967), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JUNE 2013. EXPIRATION DATE: 2018-04-30. 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 SURGEON WASHED OUT THE HIP AND REVISED THE COCR HEAD, BIPOLAR HEAD, AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131654 AMISTEM H, HA COATED STEM SIZE 5 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 163837

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention