BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS FEM A/P RESC GD SZ MED

    MDR report key: 7645085 · Received June 28, 2018

    Report

    Report Number
    1818910-2018-63363
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 6, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    NJL
    UDI-DI
    10603295109495
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TKA SURGERY WAS PERFORMED ON (B)(6) 2018. DURING THE SURGERY, THE SURGEON INSTALLED AP CUTTING GUIDE MED AFTER SIZE MEASUREMENT TO THE PATIENT¿S KNEE JOINT, AND DRILLING WAS PERFORMED NORMALLY USING THE IM INITIATOR DRILL FOR THE TIBIA. THEN, WHEN THE SURGEON TRIED TO MOUNT THE ROD TO THE GUIDE, IT WAS REPORTED THAT FEMORAL IM ALIGNMENT ROD COULD NOT BE MOUNTED TO THE CUTTING GUIDE BECAUSE THE HOLES COULD NOT FIT. THE SURGERY WAS COMPLETED BY HAMMERING THE ALIGNMENT ROD INTO THE CUTTING GUIDE WITH A HAMMER. AFTER SURGERY, THE SURGEON CHECKED THE INSTRUMENT¿S CONDITION, AND FOUND THAT IT WAS DIFFICULT TO DETACH IT BY HAND. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488402 LCS FEM A/P RESC GD SZ MED KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES NJL DEPUY ORTHOPAEDICS, INC. 1818910  10603295109495

    Patients

    Seq Age Sex Outcome Treatment
    1