BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE HC LINER 36 / F

    MDR report key: 9961668 · Received April 15, 2020

    Report

    Report Number
    3005180920-2020-00236
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 26, 2020
    Report Date
    April 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807688
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 18 MARCH 2020: LOT 123606: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2012. EXPIRATION DATE: 2017-08-31. 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 SINCE 2016. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.033 COCR BALL HEAD 12/14 Ø 36 SIZE XL +7 (K080885) LOT. 110379. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 18 MARCH 2020: LOT 110379: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2011. EXPIRATION DATE: 2016-02-28. 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 SINCE 2016.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 7 YEARS AND 3 MONTHS FROM THE PRIMARY. THE SURGEON REVISED THE CUP, HEAD AND LINER AND REPLACE THEM WITH A DUAL MOBILITY CUP DUE TO DISLOCATION THE HEAD FROM THE LINER DUE TO THE PATIENT WEIGHT. THE STEM WAS NOT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424586 LINER: CC E CC LIGHT FLAT PE HC LINER 36 / F ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL SA 01.26.3648HCT 123606 07630030807688

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention