BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3

    MDR report key: 16332043 · Received February 9, 2023

    Report

    Report Number
    3005180920-2023-00023
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720120
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECOND STEP SURGERY PERFORMED ON (B)(6) 2023, CONFIRMATION OF SURGERY RECEIVED ON 24 FEBRUARY 2023. NEW DEVICES IMPLANTED SUCCESSFULLY.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 JANUARY 2023: LOT 1902240: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2019. EXPIRATION DATE: 2024-05-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 12 JANUARY 2023: CUP: VERSAFITCUP 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø 52 (K103352) LOT. 1901418 LOT 1901418: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2019. EXPIRATION DATE: 2024-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 1901944 LOT 1901944: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. LINER: MECTACER 01.29.413 CERAMIC LINER Ø 36 / E LOT. 1900819 (NOT REGISTERED IN US) LOT 1900819: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 3 YEARS AND 3 MONTHS FROM PRIMARY FOR INFECTION. ALL DEVICES REVISED SUCCESSFULLY AND SPACER IMPLANTED.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 3 YEARS AND 3 MONTHS FROM PRIMARY FOR INFECTION. ALL DEVICES REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607527 STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.413 1902240 07630040720120

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention