BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE0

    MDR report key: 8008964 · Received October 26, 2018

    Report

    Report Number
    3005180920-2018-00827
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    September 26, 2018
    Report Date
    October 26, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804069
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 OCTOBER 2018. LOT 131626: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 JULY 2013. EXPIRATION DATE: 2022-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS REVISED: BALL HEADS: MECTACER 01.29.201, BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5, LOT 160542: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 APRIL 2016. EXPIRATION DATE: 11.04.2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH OTHER 2 SIMILAR REPORTED EVENT. CUP: VERSAFITCUP 01.26.48MB, ACETABULAR SHELL CC Ø 48, LOT 157075: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-04-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2848MHC, DOUBLE MOBILITY HC LINER Ø 48/28, LOT 157121: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MARCH 2016. EXPIRATION DATE: 2021-03-06. 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED TWO YEARS AFTER PRIMARY DUE TO INFECTION. AT FIRST A SPACER WAS IMPLANTED THEN IT WAS REMOVED AND PERMANENT HARDWARE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850488 STEM: AMISTEM H HA COATED STD STEM SIZE0 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 131626 07630030804069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention