BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/G

    MDR report key: 10535332 · Received September 15, 2020

    Report

    Report Number
    3005180920-2020-00615
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812156
    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 31 AUGUST 2020: LOT 182617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 LOT. 1907360 (K112115) BATCH REVIEW PERFORMED ON 31 AUGUST 2020: LOT 1907360: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2020. EXPIRATION DATE: 2025-01-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999609 LINER: MPACT FLAT PE HC LINER 36/G FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3652HCT 182617 07630030812156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention