BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P COLLARED STD STEM SIZE 5

    MDR report key: 13469421 · Received February 7, 2022

    Report

    Report Number
    3005180920-2022-00080
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 13, 2022
    Report Date
    February 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720243
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 JANUARY 2022 LOT 2011566: 65 ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2021. EXPIRATION DATE: 2026-JAN-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 47 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2103156: 388 ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2021. EXPIRATION DATE: 2026-JUN-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 322 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT. 2000183: 200 ITEMS MANUFACTURED AND RELEASED ON 10-MARCH-2020. EXPIRATION DATE: 2025-FEB-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 182 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 2 SIMILAR REPORTED EVENT. CUP: MPACT 01.32.158DH ACETABULAR SHELL Ø58 TWO-HOLES (K132879) LOT. 2104466: 92 ITEMS MANUFACTURED AND RELEASED ON 28-JUNE-2021. EXPIRATION DATE: 2026-JUN-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 52 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS, PERFORMED A WASHOUT AND THEN RE-IMPLANTED THE PATIENT WITH PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504745 STEM: AMISTEM P AMISTEM-P COLLARED STD STEM SIZE 5 HIP STEM CEMENTLESS LZO MEDACTA INTERNATIONAL SA 01.18.435 2011566 07630040720243

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention