BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9

    MDR report key: 7439186 · Received April 18, 2018

    Report

    Report Number
    3005180920-2018-00239
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    March 19, 2018
    Report Date
    April 18, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885693
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 APRIL 2018: MASTERLOC REFERENCE 01.39.209 CEMENTLESS TI COATED LAT STEM SIZE 9 LOT 162771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 JUNE 2016. EXPIRATION DATE: 2021-06-08. 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. MPACT REFERENCE 01.32.152DH (K132879) ACETABULAR SHELL Ø52 TWO-HOLES LOT 160472: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2016. EXPIRATION DATE: 2021-07-12. 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. COCR BALL HEAD REFERECE 01.25.025 (K072857) COCR BALL HEAD 12/14 Ø 32 SIZE XXL +10.5 LOT. 120552 LOT 120552: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 MAY 2012. EXPIRATION DATE: 2017-03-31. 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. MPACT REFERENCE 01.32.3244HCT (K103721) FLAT PE HC LINER Ø32/E LOT. 164664 LOT 164664: 18 ITEMS MANUFACTURED AND RELEASED ON 11 OCTOBER 2016. EXPIRATION DATE: 2021-09-26 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 1 YEAR AND A HALF AFTER PRIMARY THE SURGEON REVISED THE JOINT FOR A HIP INFECTION. THE INFECTION CAUSED A STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282975 MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 162771 07630030885693

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention