BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6

    MDR report key: 12187272 · Received July 19, 2021

    Report

    Report Number
    3005180920-2021-00605
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720052
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 JULY 2021. LOT 2010554: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2021. EXPIRATION DATE: 2026-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 05 JULY 2021 BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 ¿ 32 SIZE S -4 ((B)(4) LOT. 2002596. LOT 2002596: 400 ITEMS MANUFACTURED AND RELEASED ON 15-JULY-2020. EXPIRATION DATE: 2025-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    HOLD FOR REVIEW (KP) THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM WAS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090267 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2010554 07630040720052

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention