BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED STD STEM SIZE 4

    MDR report key: 11561534 · Received March 24, 2021

    Report

    Report Number
    3005180920-2021-00227
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 23, 2021
    Report Date
    March 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804298
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05.MAR.2021: LOT 148461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-FEB-2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 05 MARCH 2021: CUP: VERSAFITCUP 01.26.48MB ACETABULAR SHELL CC Ø 48 (K083116) LOT. 187023. LOT 187023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-GEN-2019. EXPIRATION DATE: 2023-12-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD (K092265) LOT. 1901454. LOT 1901454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT. 1811825. LOT 1811825: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-APR-2019. EXPIRATION DATE: 2024-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS ENTEROCOCCUS. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456627 STEM: AMISTEM C CEMENTED STD STEM SIZE 4 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.154 148461 07630030804298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention