BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 4

    MDR report key: 7498743 · Received May 9, 2018

    Report

    Report Number
    3005180920-2018-00312
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 MAY 2018. LOT 160737: 100 ITEMS MANUFACTURED AND RELEASED ON 18 MAY 2016. EXPIRATION DATE: 2021-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,96 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. COCR BALL HEAD 12/14 Ø 36, SIZE S -3.5 REFERENCE ((B)(4)). LOT 157529: 55 ITEMS MANUFACTURED AND RELEASED ON 01 MARCH 2016. EXPIRATION DATE: 2021-02-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 43 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT MPACT ACETABULAR SHELL Ø58 TWO-HOLES REFERENCE ((B)(4)). LOT 135877: 49 ITEMS MANUFACTURED AND RELEASED ON 07 AUGUST 2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 46 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT FLAT PE HC LINER Ø36/F REFERENCE ((B)(4)). LOT 140555: 70 ITEMS MANUFACTURED AND RELEASED ON 17 APRIL 2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 67 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 15 REFERENCE (B)(4). LOT 115662: 150 ITEMS MANUFACTURED AND RELEASED ON 09 APRIL 2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 64 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 REFERENCE (B)(4). LOT 115663: 299 ITEMS MANUFACTURED AND RELEASED ON 03 APRIL 2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 212 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(4) 2018 THE SALES AGENT INFORMED MEDACTA THAT A PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PLANS TO REMOVE ALL HARDWARE AND IMPLANT A SPACER ON (B)(6) 2018. ON (B)(4) 2018 MEDACTA WAS INFORMED THAT THE SURGERY WAS COMPLETED ON (B)(6) 2018. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER. THE PATHOGEN IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340221 AMISTEM H HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 160737 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention