BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F

    MDR report key: 13078024 · Received December 23, 2021

    Report

    Report Number
    3005180920-2021-01008
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07.12.2021. LOT 2107103: (B)(4). EXPIRATION DATE: 2026-06-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 07.12.2021 MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 2100273: (B)(4). EXPIRATION DATE: 2026-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    AT ONE WEEK AFTER THE PREVIOUS REVISION, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS THE SECOND REVISION SURGERY PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974488 MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 2107103 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention