BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 9523301 · Received December 27, 2019

    Report

    Report Number
    3005180920-2019-01102
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 DECEMBER 2019: LOT 1810220: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DIC-2018. EXPIRATION DATE: 2023-12-03. 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 DEVICES INVOLVED IN THE EVENT BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 LOT. 1810802 (K112115). BATCH REVIEW PERFORMED ON 16 DECEMBER 2019: LOT 1810802: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2019. EXPIRATION DATE: 2024-02-28. 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

    REVISION SURGERY PERFORMED AFTER 6 MONTHS FROM THE PRIMARY DUE TO DISLOCATION. AFTER THE PRIMARY, THE PATIENT HAD 2 CLOSED REDUCTIONS DUE TO 2 DISLOCATIONS ON SEPARATE OCCASIONS. THE SURGEON DECIDED TO OPERATE AND REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317478 LINER: MPACT FLAT PE HC LINER Ø36/E FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 1810220 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention