BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEM: AMISTEM-P STD SIZE 3

    MDR report key: 9254770 · Received October 30, 2019

    Report

    Report Number
    3005180920-2019-00914
    Event Type
    Death
    Date Received
    October 30, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720021
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 1901563: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MAY 2019. EXPIRATION DATE: 2024-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON (B)(6) 2019: CUP: VERSAFITCUP 01.26.56MB ACETABULAR SHELL CC Ø 56 (K083116), LOT 1901405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUNE 2019. EXPIRATION DATE: 2024-05-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28 (K092265), LOT 1901458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MAY 2019. EXPIRATION DATE: 2024-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115), LOT 1901932: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2019. EXPIRATION DATE: 2024-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. WHEN THE FINAL IMPLANTS WERE IN, AND THE SURGEON WAS CLOSING HIS INCISION, THE PATIENT'S HEART RATE DROPPED AND REQUIRED RESUSCITATION EFFORTS. THE PATIENT WAS NOT ABLE TO BE RESUSCITATED (PASSED AWAY). THERE WAS NO INDICATION THAT THE IMPLANTED DEVICES LED TO THIS EVENT. DURING THIS CASE HAVE BEEN USED NON CEMENTED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048929 STEM: AMISTEM-P STD SIZE 3 UNCEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 1901563 07630040720021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention