BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 32/E

    MDR report key: 10600390 · Received September 29, 2020

    Report

    Report Number
    3005180920-2020-00676
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    September 4, 2020
    Report Date
    September 29, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811913
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 SEPTEMBER 2020: LOT 1909323: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2019. EXPIRATION DATE: 2024-11-25. 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. ANOTHER DEVICE INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 (K112115) BATCH REVIEW PERFORMED ON 11 SEPTEMBER 2020. LOT 1903854: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUL-2019. EXPIRATION DATE: 2024-07-14. 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 REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063730 LINER: MPACT FLAT PE HC LINER 32/E FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3244HCT 1909323 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention