BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4

    MDR report key: 8077512 · Received November 16, 2018

    Report

    Report Number
    3005180920-2018-00907
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803215
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2018: LOT 180805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MAY 2018. EXPIRATION DATE: 2032-05-15. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY "CLINIAL" AFFAIRS DIRECTOR: HIP REVISION SURGERY OCCURRED 2 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. REASON FOR REVISION IS A FEMORAL FRACTURE PROBABLY OCCURRED DURING POSTOPERATIVE REHABILITATION. IN THIS PERIOD OF TIME, ACCIDENTAL TRAUMA OR SUDDEN MOVEMENTS ON A WEAKENED BONE DUE TO THE NORMAL INTRAOPERATIVE FEMORAL PREPARATION MAY FACILITATE FRACTURE OCCURRENCE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 2 MONTHS AFTER PRIMARY DUE TO BONE FEMUR FRACTURE. THE SURGEON REVISED THE STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917627 MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 180805 07630030803215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention