BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMIS-K LONG SIZE 4S1 LENGTH 200MM

    MDR report key: 19328732 · Received May 16, 2024

    Report

    Report Number
    3005180920-2024-00337
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971265585
    PMA / PMN Number
    K220405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 MAY 2024: LOT 2201597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUNE-2022. EXPIRATION DATE: 2027-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 03 MAY 2024: BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M 0 (K112115) LOT 178808A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2023. EXPIRATION DATE: 2028-07-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER THE PRIMARY, 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
    634514 STEM: AMIS-K LONG SIZE 4S1 LENGTH 200MM HIP CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 2201597 07630971265585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention