BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 4 STD

    MDR report key: 5991452 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00497
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 30, 2016
    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

    BATCH REVIEWS PERFORMED ON (B)(6) 2016. LOT 136190: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 FEBRUARY 2014. EXPIRATION DATE: 2019-01-31. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5, CODE (B)(4), LOT. 131492 (K112115); (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JUNE 2013. EXPIRATION DATE: 2018-05-31. 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. VERSAFITCUP ACETABULAR SHELL Ø 54, CODE (B)(4), LOT. 133455 (K083116); (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2013. EXPIRATION DATE: 2018-09-30. 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. VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 54/28, CODE (B)(4), LOT. 104164 (K092265); (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 FEBRUARY 2011. EXPIRATION DATE: 2015-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED ALL HARDWARE AND PLACED IN 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
    641456 AMISTEM H, HA COATED STEM SIZE 4 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 136190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention