BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3

    MDR report key: 12758191 · Received November 7, 2021

    Report

    Report Number
    3005180920-2021-00852
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885631
    PMA / PMN Number
    K160289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08-OCT-2021: LOT 162125: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2016. EXPIRATION DATE: 2021-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: 5 YEARS AFTER PRIMARY CEMENTLESS THA THE PATIENT REPORTS PAIN AND THE RADIOGRAPH REVEALS THAT THE FEMORAL STEM IS BROKEN AT NECK LEVEL. WE HAVE ONE RADIOGRAPH, TAKEN AFTER THE FRACTURE TOOK PLACE, SO WE CANNOT DRAW ANY CONCLUSION. THE EVENT IS EXTREMELY RARE. ANALYSIS OF THE EXPLANTS IS MANDATORY IN ORDER TO UNDERSTAND THE MECHANISMS OF THE FRACTURE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO STEM NECK BREAKAGE 4 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY (STEM AND HEAD WERE REPLACED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659306 STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3 CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 01.39.203 162125 07630030885631

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention