BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 9

    MDR report key: 8417169 · Received March 13, 2019

    Report

    Report Number
    3005180920-2019-00161
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    February 16, 2019
    Report Date
    March 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040715812
    PMA / PMN Number
    K173267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A FRACTURE IN THE CALCAR REGION. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 12 MARCH 2019: LOT 180715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2018. EXPIRATION DATE: 2023-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE ALREADY BEEN SOLD WITHOUT ANY OTHER SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE INFORMED ABOUT A SURGERY PLANNED FOR THE NEXT DAY DUE TO PATIENT FEELING PAIN ON 'TOUCHING HIS TOES' DURING ROUTINE PHYSIOTHERAPY POST-SURGERY. THE PRIMARY SURGERY WAS DONE THREE WEEKS BEFORE. INVESTIGATION VIA CT SCAN SHOWED A SMALL FRACTURE AT THE CALCAR. THE SURGEON DID NOT THINK THAT THE STEM HAD SUBSIDED NOTICEABLY. HE DID NOT EXPLANT THE STEM AND RESOLVED THE FRACTURE WITH TWO CERCLAGE WIRES, ONE ABOVE AND ONE BELOW THE FRACTURE. PRIMARY IMPLANTS IN SITU ARE SIZE 9 LAT+ MASTERLOC STEM, 54 VERSAFIT CUP, LINER E CERAMIC, 36-S CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208926 STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 9 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 180715 07630040715812

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention