BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 10

    MDR report key: 11481960 · Received March 15, 2021

    Report

    Report Number
    3005180920-2021-00221
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    February 16, 2021
    Report Date
    March 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040715829
    PMA / PMN Number
    K173267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 MARCH 2021. LOT 180716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2018. EXPIRATION DATE: 2023-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 3 MARCH 2021: BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M 0 (K112115) LOT. 181303. LOT 181303: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-06-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: MPACT 01.32.4052HCT FLAT PE HC LINER Ø40/G (K122641) LOT. 177544 LOT 177544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2018. EXPIRATION DATE: 2023-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CUP: MPACT 01.38.060DH ACETABULAR SHELL Ø60 TWO-HOLE (K171966) LOT. 153948 LOT 153948: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-FEB-2016. EXPIRATION DATE: 2021-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER 2 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381123 STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS STEM SIZE 10 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.39.410 180716 07630040715829

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention