BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø40/G

    MDR report key: 14072432 · Received April 11, 2022

    Report

    Report Number
    3005180920-2022-00251
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812286
    PMA / PMN Number
    K122641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 MARCH 2022: LOT 165678: (B)(4). EXPIRATION DATE: 2021-10-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4). ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 21 MARCH 2022: BALL HEADS: MECTACER 01.29.215 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8 (K112115) LOT 141175: (B)(4). . EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4).

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 3 YEARS 11 MONTHS AFTER THE PRIMARY DUE TO HIP LUXATION (LINER FROM HEAD). THE SURGEON REVISED THE MEDACTA LINER WITH A COMPETITOR CONSTRAINED LINER AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490006 MPACT FLAT PE HC LINER Ø40/G HIP SHELL LINER LZO MEDACTA INTERNATIONAL SA 01.32.4052HCT 165678 07630030812286

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention