BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED STD STEM SIZE 3

    MDR report key: 11337496 · Received February 17, 2021

    Report

    Report Number
    3005180920-2021-00118
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    January 15, 2021
    Report Date
    February 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804281
    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 15.FEBRUARY.2021: LOT 2002911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2020. EXPIRATION DATE: 2025-07-05. 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. ADDITIONAL IMPLANT INVOLVED: CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52 (K143453) LOT. 2000204. BATCH REVIEW PERFORMED ON 15.FEBRUARY.2021: LOT 2000204: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-JUL-2020. EXPIRATION DATE: 2025-06-23. 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. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 165965 BATCH REVIEW PERFORMED ON 15.FEBRUARY.2021: LOT 165965: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2017. EXPIRATION DATE: 2021-12-19. 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. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT. 2001457. BATCH REVIEW PERFORMED ON 15.FEBRUARY.2021: LOT 2001457: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2020. EXPIRATION DATE: 2025-06-02. 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 MONTH AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233309 STEM: AMISTEM C CEMENTED STD STEM SIZE 3 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.153 2002911 07630030804281

    Patients

    Seq Age Sex Outcome Treatment
    1