BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS RP INSRT SZ5 5MM

    MDR report key: 20407270 · Received October 9, 2024

    Report

    Report Number
    1818910-2024-21158
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 9, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295052425
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UPON FURTHER REVIEW, IT HAS BEEN DETERMINED THAT THIS REPORT (MRN 1818910-2024-21158) HAS BEEN SUBMITTED IN ERROR. FURTHER UPDATES WILL ONLY BE PROVIDED IF ADDITIONAL INFORMATION IS RECEIVED THAT CHANGES THE REGULATORY DETERMINATION.

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, 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

    STUDY NO: (B)(4). CLINICAL ADVERSE EVENTS RECEIVED FOR KNEE STIFFNESS, DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: DEFINITELY, PROCEDURE RELATED: DEFINITELY, DATE OF EVENT: 16 SEP 2024, DATE OF IMPLANT: ON (B)(6) 2023, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: PHYSICAL THERAPY, DEPUY SYNTHES PRODUCT USED: COMPONENT TYPE: FEMORAL COMPONENT, CATALOG NUMBER: 150410105, LOT NUMBER ID: 3851774, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL BASE COMPONENT, CATALOG NUMBER: 150680006, LOT NUMBER ID: 4022166, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL STEM, CATALOG NUMBER: 151310110, LOT NUMBER ID: J8383W, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL SLEEVE, CATALOG NUMBER: 151111201, LOT NUMBER ID: J94Z36, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL INSERT COMPONENT, CATALOG NUMBER: 151650505, LOT NUMBER ID: 3787761, UDI: (B)(4). COMPONENT TYPE: CEMENT, CATALOG NUMBER: 3003940002, LOT NUMBER ID: AX42AK0B03, DESCRIPTION: NO INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16387 ATTUNE PS RP INSRT SZ5 5MM ATTUNE IMPLANT : KNEE TIBIAL INSERT NJL DEPUY IRELAND - 9616671 3787761 10603295052425

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention UNK BONE CEMENT 3003940002, AX42AK0B03.