BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø40/G

    MDR report key: 14109994 · Received April 14, 2022

    Report

    Report Number
    3005180920-2022-00253
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 15, 2022
    Report Date
    July 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040731270
    PMA / PMN Number
    K183582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 MARCH 2022: LOT 1810856: (B)(4). EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM C 01.18.151 CEMENTED STD STEM SIZE 1 (K103189) LOT. 1903200 BATCH REVIEW PERFORMED ON 21 MARCH 2022: LOT 1903200: (B)(4). EXPIRATION DATE: 2024-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.212 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE S - 4 (K112115) LOT. 1908999 BATCH REVIEW PERFORMED ON 21 MARCH 2022: LOT 1908999: (B)(4). EXPIRATION DATE: 2025-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, 2ND STAGE REVISION HAS BEEN PERFORMED,. SPACER REMOVED AND FINAL DEVICES IMPLANTED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 MONTHS FROM THE PRIMARY THE SURGEON REMOVED ALL COMPONENTS (THE CUP WAS FROM A COMPETITOR), PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133431 LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø40/G ACETABULR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.4052HC10A 1810856 07630040731270

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention