BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE FEMORAL COMPONENT SIZE 6 RIGHT

    MDR report key: 6803629 · Received August 18, 2017

    Report

    Report Number
    3005180920-2017-00458
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 19, 2017
    Report Date
    September 19, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825507
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PACKAGING ONLY RECEIVED ON 25 AUGUST 2017. ON 07 SEPTEMBER 2017 THE PACKAGING AND CLEANING MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED PACKAGING AND COMMENTED AS FOLLOWS: BOTH THE OUTER AND THE INNER BLISTER CONTAINING THE INVOLVED FEMORAL COMPONENT WERE FOUND CRACKED DURING SURGERY. MOREOVER, ALSO THE CARTON BOX SHOWS SIGNS OF DAMAGE THAT COULD BE CORRELATED TO THE ONES FOUND ON THE TWO BLISTERS (SAME POSITION). ACCORDING TO INTERNAL PROCEDURES, THE OPERATOR INVOLVED IN THE MANUFACTURING PROCESS MUST 100% CHECK THE INTEGRITY OF THE WHOLE PACKAGING OF EACH SINGLE ITEM OF THE LOT. CONSIDERING THAT IT IS INDICATED THAT THE CLAIMED PIECE WAS NOT RELEASED WITH SUCH DAMAGE BY MEDACTA INTERNATIONAL SA, THE TWO FOLLOWING ROOT CAUSES COULD BE EVALUATED: NON-CONFORMING SHIPPING MODALITY. CONSIDERING THE EXTENT OF THE BREAKAGE, IT CAN BE REASONABLY EXCLUDED THAT THE CLAIMED DAMAGE COULD HAVE BEEN GENERATED FOLLOWING THE VALIDATED SHIPPING INSTRUCTIONS. POOR HANDLING OF THE PRODUCT. IT CAN'T BE EXCLUDED THAT DURING SHIPMENT/STORAGE IN THE HOSPITAL THE BLISTER COULD HAVE BEEN ACCIDENTALLY DAMAGED. FOR ALL THE ABOVE, THE MOST PROBABLE ROOT CAUSE COULD BE FOUND IN AN ACCIDENTAL HANDLING DAMAGE OCCURRED AFTER THE PULLING OUT OF THE BLISTER FROM THE CARTON BOX. ON 08 SEPTEMBER 2017 THE TECHNICAL DIRECTOR INVOLVED IN THE ISSUE, CONFIRMED THAT THE EVENT WAS NOT DUE TO ANY PACKAGING DEFECT, BUT MORE PROBABLY TO AN HANDLING DAMAGE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 AUGUST 2017. LOT 155543: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 DECEMBER 2015. EXPIRATION DATE: 2020-11-03. 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 INFORMATION RECEIVED ON 18 AUGUST 2017 AND INCLUDES: THE PATIENT WAS UNDER ANESTHESIA WHEN THE EVENT WAS DETECTED. NO OTHER IMPLANT OPTION WOULD BE AVAILABLE FOR A GMK-HINGE FEMORAL COMPONENT. THE PACKAGING WILL BE RETURNED TO MEDACTA INTERNATIONAL FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING FINAL IMPLANT ASSEMBLY, A DOUBLE PUNCTURE WAS FOUND IN THE PACKAGING OF THE SIZE 6 RIGHT GMK-HINGE FEMORAL COMPONENT. BOTH THE INTERNAL AND EXTERNAL PLASTIC PILL WERE CRACKED. THE TYVEK WAS NOT COMPROMISED. THE STERILITY WAS COMPROMISED. THE IMPLANT WAS REWASHED AND THEN AUTOCLAVED. THE TOTAL TIME DELAY WAS IN EXCESS OF 3 HOURS. THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585616 GMK-HINGE FEMORAL COMPONENT SIZE 6 RIGHT KNEE FEMORAL COMPONENT KRO MEDACTA INTERNATIONAL SA 155543 07630030825507

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other