BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 9401244 · Received December 3, 2019

    Report

    Report Number
    3005180920-2019-01042
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 NOVEMBER 2019. LOT 1811217: 160 ITEMS MANUFACTURED AND RELEASED ON 1-MAY-2019. EXPIRATION DATE: 2024-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 146 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 25 NOVEMBER 2019. BALL HEADS: COCR 01.25.030 COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5 (K080885) LOT. 162372 LOT 162372: 100 ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2016. EXPIRATION DATE: 2021-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 84 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 5 MONTHS FROM THE PRIMARY DUE TO THE DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199570 LINER: MPACT FLAT PE HC LINER Ø36/E LINER FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 1811217 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention