BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3

    MDR report key: 17077538 · Received June 7, 2023

    Report

    Report Number
    3005180920-2023-00421
    Event Type
    Injury
    Date Received
    June 7, 2023
    Date of Event
    June 27, 2023
    Report Date
    June 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720120
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-JUN-2023 LOT 2010561: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2021. EXPIRATION DATE: 2026-01-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: LINER: MPACT DM 01.26.2858MHC DOUBLE MOBILITY HC LINER 28/DMI (K092265) LOT 2242684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-NOV-2022. EXPIRATION DATE: 2027-11-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT 173284B: (B)(4) ITEMS REWORKED AND RELEASED ON 18-JAN-2023. EXPIRATION DATE: 2027-12-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.158MB DOUBLE MOBILITY ACETABULAR SHELL Ø58 (K143453) LOT 2111695: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2022. EXPIRATION DATE: 2027-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON WANTED TO REVISE THE PATIENT BECAUSE HE WAS NOT SATISFIED BY THE WAY HE INITIALLY IMPLANTED IMPLANTS DURING THE PRIMARY. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ISSUES WERE DETECTED WITH THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509821 STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.413 2010561 07630040720120

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention