BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 9410015 · Received December 4, 2019

    Report

    Report Number
    3005180920-2019-01011
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19.NOV.2019. LOT 121334: 60 ITEMS MANUFACTURED AND RELEASED ON 02-JULY-2012. EXPIRATION DATE: 31/05/2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 58 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION: A STRONGLY LATERALIZED STEM IS IMPLANTED IN PRIMARY CEMENTLESS THA IN AN OVERWEIGHT FEMALE PATIENT IN 2013. SHE THEN DEVELOPS INFECTION AND TWO FURTHER HIP OPERATIONS ARE CARRIED OUT; IN LATE 2019 THE STEM NECK FRACTURES. THE EXPLANT SHOWS EVIDENT SIGNS OF DAMAGE TO THE NECK, ALSO IN PRECISE CORRESPONDENCE TO THE CRACK INITIATION. SUCH DAMAGES ARE A RECOGNIZED CAUSE OF FATIGUE FRACTURES. IT IS HIGHLY PROBABLE THAT THOSE SIGNS HAVE BEEN INFLICTED UPON THE IMPLANTED STEM DURING THE SUCCESSIVE SURGERIES. THIS IS KNOWN TO BE POSSIBLE AND POTENTIALLY EXTREMELY DIFFICULT TO RECOGNIZE. VISUAL INSPECTION: DURING THE VISUAL INSPECTION WE CAN SEE CLEARLY THAT THE POLISHED NECK OF THE STEM SHOWS SOME BURNS AND SCRATCHES. WE DON'T KNOW IF THESE BURNS HAVE BEEN CAUSED BY THE ELECTRO-CUTTER DURING THE PRIMARY SURGERY OR DURING THE DOUBLE REVISION SURGERY. SOME DEEP SCRATCHES ARE PRESENT ON THE TOP (11 O'CLOCK ) OF THE POLISHED NECK; HALF O THEM ON THE LEFT SIDE OF THE BREAKAGE AND HALF OF THEM ON THE RIGHT SIDE OF THE BREAKAGE. IF THE TWO BROKEN PIECES ARE COMBINED TOGETHER THERE IS A PERFECT MATCH OF THIS SCRATCH. FOR THIS REASON WE CAN AFFIRM THAT THESE DEEP SCRATCHES (SURFACE INDENTATION ) WAS PRESENT ON THE POLISHED NECK BEFORE THE BREAKAGE OCCURED. LOOKING AT THE FRACTURED SECTION WE CAN EASILY SEE THE WAVES OF FATIGUE FRACTURE STARTING FROM THE TOP (11 O'CLOCK ) OF THE POLISHED NECK, THIS CONFIRM THE ROOT CAUSE OF THE FRACTURE AS AN HEAVY INDENTATION OF THE MIRROR POLISHED NECK REGION. BECAUSE THESE INDENTATIONS HAVE BEEN IDENTIFIED AS A POSSIBLE SOURCE OF CRACK INITIATION FOR VERY SIMILAR CLINICAL CASES, THE PRESENCE OF THE SCRATCH ON THE POLISHED NECK OF THE STEM SUBJECT OF THIS CLAIM, CAN BE VERY LIKELY CONSIDERED THE MAIN ROOT CAUSE OF THE BREAKAGE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE BREAKAGE OF THE STEM NECK. THE PATIENT HAD THE PRIMARY SURGERY IN (B)(6) 2013 AND WAS THEN REVISED TWICE DUE TO INFECTION (2014 AND 2016). THE STEM WAS IMPLANTED IN 2013 AND REVISED ON THE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203549 STEM: AMISTEM H HA COATED LAT STEM SIZE 3 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 121334 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention