BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 4 CEM

    MDR report key: 16897414 · Received May 9, 2023

    Report

    Report Number
    1818910-2023-09943
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    April 28, 2023
    Report Date
    May 9, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295042587
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY; NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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 LOT NUMBER: 1111111 DOES NOT REFLECT A VALID FINISHED GOODS LOT NUMBER. THEREFORE, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO VALID FINISHED GOODS LOT NUMBER WAS PROVIDED FOR THIS DEVICE. H10 ADDITIONAL NARRATIVE: ADDED: G4 D1, D2, D4 AND D10.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    PATIENT WAS REVISED DUE TO IMPLANTS SUBSIDED , BONE QUALITY NOT GOOD. WENT BACK IN WITH LONGER STEM . DOI: UNKNOWN. DOR: (B(6) 2023. AFFECTED SIDE: RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906986 ATTUNE RP TIB BASE SZ 4 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS INC US 1506-10-004 1111111 10603295042587
    800985 ATTUNE RP TIB BASE SZ 4 CEM ATTUNE IMPLANT : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS INC US 1506-10-004 1111111 10603295042587

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention 4 5MM INSERT PS| ATTUNE PS FB INSRT SZ 4 5MM| ATTUNE PS FEM RT SZ 4 CEM| ATTUNE PS SIZE 4 FEMUR| ATTUNE RP TIB BASE SZ 4 CEM