BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 4

    MDR report key: 7549086 · Received May 29, 2018

    Report

    Report Number
    3005180920-2018-00380
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 29, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885532
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 MAY 2018; LOT 164826: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 OCTOBER 2016. EXPIRATION DATE:2021-10-06 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. OTHER DEVICE INVOLVED: COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5 REFERENCE 01.25.032 (K080885); LOT 172871: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 SEPTEMBER 2017. EXPIRATION DATE: 2022-09-11 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.

    Description of Event or Problem · 1

    THE SAME DAY OF THE SURGERY THE PATIENT WAS REOPENED FOR STEM ROTATION INSIDE THE FEMORAL CANAL. STEM AND HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391888 MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 164826 07630030885532

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability