BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE RP TIB BASE SZ 3 CEM

    MDR report key: 11320906 · Received February 12, 2021

    Report

    Report Number
    1818910-2021-02866
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    August 20, 2020
    Report Date
    February 9, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295492153
    PMA / PMN Number
    P830055
    Removal / Correction Number
    1818910-02/22/2021-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: UPDATE 24-FEB-2021: THE INVESTIGATION WAS RE-OPENED DUE TO NR-0156854. EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE PACKAGING WAS DAMAGED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE DHR REVIEW IDENTIFIED THE FOLLOWING: PRODUCT CODE 150680003, WORK ORDER: (B)(4) WAS MANUFACTURED ON THE 08 JULY 2020. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIAL MET SPECIFICATION. THERE WERE NO NON-CONFORMANCES (NC) FOUND TO BE ASSOCIATED WITH WORK ORDER: (B)(4). THERE WERE NO SCRAP PARTS FOUND TO BE ASSOCIATED WITH WORK ORDER: (B)(4). THERE WAS NO REPROCESSING ASSOCIATED WITH WORK ORDER: (B)(4).

    Additional Manufacturer Narrative · 0

    H7 AND H9: RECALL NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT WHEN NURSE WENT TO OPEN THE SIZE 3 RP TIBIA, THE PACKAGING WAS HARD PLASTIC AND LOOKED LIKE IT WAS EXPOSED TO HEAT AS IT WAS PRESSURIZED. SURGEON ASKED FOR A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222301 ATTUNE RP TIB BASE SZ 3 CEM KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-80-003 9557440 10603295492153

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female