BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT 01.32.2837HCT FLAT PE HC LINER Ø28/B

    MDR report key: 12787117 · Received November 10, 2021

    Report

    Report Number
    3005180920-2021-00877
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    October 15, 2021
    Report Date
    November 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811531
    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 19 OCTOBER 2021. LOT 188502: (B)(4). EXPIRATION DATE: 2023-NOV-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 19 OCTOBER 2021. MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 2006678: (B)(4). EXPIRATION DATE: 2025-SEP-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER 2 MONTHS AFTER THE PRIMARY SURGERY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688779 MPACT 01.32.2837HCT FLAT PE HC LINER Ø28/B HIP LINER FLAT LPH MEDACTA INTERNATIONAL SA 01.32.2837HCT 188502 07630030811531

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other