BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 32/F

    MDR report key: 11130978 · Received January 7, 2021

    Report

    Report Number
    3005180920-2021-00028
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    December 12, 2020
    Report Date
    January 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811951
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07.JAN.2021: LOT 167597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2017. EXPIRATION DATE: 2022-01-31. 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 ITEM INVOLVED IN THE COMPLAINT: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 172253. BATCH REVIEW PERFORMED ON 07.JAN.2021: LOT 172253: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2017. EXPIRATION DATE: 2022-07-05. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER, 3 YEARS 4 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27910 LINER: MPACT FLAT PE HC LINER 32/F FLAT LINER HC LPH MEDACTA INTERNATIONAL SA 01.32.3248HCT 167597 07630030811951

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention