BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 1 R

    MDR report key: 12141654 · Received July 9, 2021

    Report

    Report Number
    3005180920-2021-00573
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821370
    PMA / PMN Number
    K102437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER DEVICE RECEIVAL ON (B)(6) 2021 THE MIX-UP HAS BEEN CONFIRMED, A BOX LABELED WITH THE REF. (B)(4), LOT 082864A, (GMK PRIMARY CEMENTLESS FEMUR SIZE 4 RIGHT) WAS FOUND TO INCLUDE REF. (B)(4), LOT 082446 (GMK REVISION PS FEMUR SIZE 1 RIGHT).

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02-JUL-2021. LOT 082446D: 1 ITEM MANUFACTURED AND RELEASED ON 12-MAR-2019. EXPIRATION DATE: 2024-02-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. ADDITIONAL ITEM INVOLVED IN THE MIX-UP: GMK-PRIMARY 02.07.2104R FEMUR PS CEMENTLESS SIZE 4 R LOT. 082864A. BATCH REVIEW PERFORMED ON 02-JUL-2021. LOT 082864A: 1 ITEM MANUFACTURED AND RELEASED ON 13-MAR-2019. EXPIRATION DATE: 2024-02-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. PRELIMINARY INVESTIGATION: THE MIX-UP HAS BEEN CONFIRMED, A BOX LABELED WITH THE REF. (B)(4), LOT 082864A, (GMK PRIMARY CEMENTLESS FEMUR SIZE 4 RIGHT) WAS FOUND TO INCLUDE REF. 02.07.2401R, LOT 082446 (GMK REVISION PS FEMUR SIZE 1 RIGHT) AND VICEVERSA. A RECALL OF THE LOT 082446D WAS NECESSARY TO CONFIRM THE MIX-UP AND WE HAVE FOUND THE SIZE 4 RIGHT - LOT 082864A OF GMK PRIMARY CEMENTLESS - IN THE BOX LABELED WITH THE LOT 082446D. LETTERS A AND D ARE PRESENT AT THE END OF THE LOT BECAUSE THEY ARE ASSIGNED IN THE RE-STERILIZATION PROCESS OF LOTS, AS PER MEDACTA INTERNATIONAL INTERNAL PROCEDURE. BOTH LOTS INVOLVED IN THE ACTION ARE COMPOSED OF 1 DEVICE EACH. COUNTRY INVOLVED IN THE RECALL: (B)(6).

    Description of Event or Problem · 1

    DURING THE SURGERY, OPENING THE GMK-PRIMARY FEMUR SIZE 4 BOX IT WAS FOUND A GMK-REVISION SIZE 1 ITEM. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A SIZE 4 GMK-PRIMARY NARROW IMPLANT AS A BACK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044558 GMK-REVISION FEMUR REVISION PS SIZE 1 R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.2401R 082446D 07630030821370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other