BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER: CC E CC LIGHT HOODED PE HC FIXED LINER Ø 32 / E

    MDR report key: 8164779 · Received December 14, 2018

    Report

    Report Number
    3005180920-2018-01008
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 16, 2018
    Report Date
    December 14, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807565
    PMA / PMN Number
    K103352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 DECEMBER 2018; LOT 183974: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JUNE 2018 . EXPIRATION DATE: 2023-06-13. 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. ADDITIONAL IMPLANT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 (K103352), LOT 181695: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JUNE 2018. EXPIRATION DATE: 2023-06-06. 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

    IT WAS NOT POSSIBLE TO COUPLE THE INLAY WITH THE CUP. ANOTHER LINER OF THE SAME SIZE, BUT WITH A DIFFERENT LOT WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002907 LINER: CC E CC LIGHT HOODED PE HC FIXED LINER Ø 32 / E HIP PE LINER LZO MEDACTA INTERNATIONAL SA 183974 07630030807565

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other