BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7955804 · Received October 11, 2018

    Report

    Report Number
    3005180920-2018-00770
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807688
    PMA / PMN Number
    K103352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 OCTOBER 2018. LOT 180143: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 MAY 2018. EXPIRATION DATE: 2022-09-24. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER PIECE INVOLVED: LINER CC E CC LIGHT FLAT PE LINER Ø 32 / E REFERENCE 01.26.3244STT (K103352). LOT 180131: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MAY 2018. EXPIRATION DATE: 2022-09-24. NO PIECES HAVE BEEN SOLD UP TO NOW. INVESTIGATION PERFORMED BY WASHING AND PACKAGING MANAGER ON 11 OCTOBER 2018. IMMEDIATELY AFTER THE RECEIPT OF THE COMPLAINT WE CHECKED THE ENTIRE LOT 180131 ((B)(4) PIECES). ALL PIECES WERE FOUND. THE PICTURES RECEIVED "CONFIRME" THAT THE COMPONENTS WERE MIXED UP AND THE IMMEDIATE CHECK CONFIRMED THE MIX UP OF THE COMPONENTS. DURING THE INVESTIGATION WE DISCOVERED THAT THE TWO LOTS WERE PROCESSED AT THE CARTON BOX STAGE ON THE SAME DAY. MOREOVER, BOTH LOTS ARE INVOLVED IN A ANOMALY, BOTH LOTS WERE REWORKED IN THE CLEANING ROOM. DURING THE MATCHING OF THE PIECES WITH THE PACKAGING THE OPERATOR WRONGLY ASSOCIATED THE PIECES WITH THEIR BOX. DUE TO THE EVENT THE PROCEDURE HAS BEEN REVIEWED, THE OPERATORS HAVE BEEN MADE AWARE ABOUT THE ISSUE AND A COMPUTERISED SYSTEMS HAVE BEEN INTRODUCED IN ORDER TO PREVENT SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING SURGERY THE SURGEON WENT TO USE AN IMPLANT THAT WAS PACKAGED IN A BOX LABELLED AS A 36/F LINER. WHEN THE SURGEON IMPLANTED THE LINER INTO A 56MM CC TRIO CUP, THE LINER SEEMED TO BE TOO SMALL. UPON FURTHER INVESTIGATION, THE AGENT AND SURGEON NOTICED THAT THE BOX AND STICKERS WERE LABELLED WITH 36/F YET THE IMPLANT AND IMPLANT BLISTER PACK WAS LABELLED 32/E LINER. THE AGENT USED A SECOND IMPLANT TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797083 LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F PE FLAT LINER LZO MEDACTA INTERNATIONAL SA 180143 07630030807688

    Patients

    Seq Age Sex Outcome Treatment
    1 Other