BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 6

    MDR report key: 9290196 · Received November 7, 2019

    Report

    Report Number
    3005180920-2019-00928
    Event Type
    Death
    Date Received
    November 7, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 7, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720151
    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 07 NOVEMBER 2019: LOT 180748: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JULY-2018. EXPIRATION DATE: 2023-06-27. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: PATIENT REOPERATED FEW MONTHS AFTER PRIMARY THA DUE TO DISLOCATION. IMPLANTS WERE REMOVED. CEMENT (NOT MEDACTA) WAS APPLIED AFTER REMOVAL OF IMPLANTS AND THE PATIENT HAD PULMONARY EMBOLISM AND PASSED AWAY. NO REASON TO SUSPECT THAT THE EXPLANTED DEVICES HAD ANY ROLE IN THE PULMONARY EMBOLISM. THE REASON FOR REOPERATION (DISLOCATION OF THA WITH A VERY LARGE HEAD) SHOULD NOT BE SOUGHT IN A DEFECTIVE IMPLANT. OTHER IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON OCTOBER 23RD, 2019: BALL HEADS: MECTACER 01.29.212 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S - 4 (K112115) LOT. 189653 LOT 189653: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-LUG-2018. EXPIRATION DATE: 2023-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENTS (INFECTION AND DISLOCATION).

    Description of Event or Problem · 1

    ABOUT 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR A DISLOCATION. ACETABULAR COMPONENTS FROM A COMPETITOR. WHEN THE PATIENT WAS OPENED THE SURGEON NOTICED AN INFECTION AND DECIDED TO REMOVE ALL THE IMPLANTS. AFTER ADDING CEMENT OF COMPETITOR (NO MEDACTA CEMENT USED) THE PATIENT WENT THROUGH PULMONARY EMBOLISM AND PASSED AWAY. THE SURGEON WAS IMPLANTING ONLY COMPETITOR IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084343 STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 6 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 180748 07630040720151

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R