BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM P LAT STEM SIZE 6

    MDR report key: 20050064 · Received August 23, 2024

    Report

    Report Number
    3005180920-2024-00665
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 23, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720151
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05-AUG-2024 LOT 2304086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2023. EXPIRATION DATE: 2028-06-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 05-AUG-2024 CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES (K132879) LOT 2316704: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2023. EXPIRATION DATE: 2028-11-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO SUBSIDENCE OF THE CUP AND STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE CUP, LINER, HEAD AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312468 AMISTEM P LAT STEM SIZE 6 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2304086 07630040720151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention