BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 2 STD

    MDR report key: 6314106 · Received February 9, 2017

    Report

    Report Number
    3005180920-2017-00029
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    January 10, 2017
    Report Date
    February 9, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 06 FEBRUARY 2017. LOT 112363: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 AUGUST 2011. EXPIRATION DATE: 2016-06-30. 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. MECTACER BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0, CODE 38.39.7175.285.00, LOT. 090544 (K073337) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 FEBRUARY 2009. EXPIRATION DATE: 2014-01-31. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN AT THIS TIME. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99800 AMISTEM H, HA COATED STEM SIZE 2 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 112363

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention