BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATUN PRESSFIT STR STEM10X110MM

    MDR report key: 20407199 · Received October 9, 2024

    Report

    Report Number
    1818910-2024-21155
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 16, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295043492
    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 1818910-2024-21155) 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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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)(6). 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: (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
    637244 ATUN PRESSFIT STR STEM10X110MM KNEE STEMS JWH DEPUY IRELAND - 9616671 J8383W 10603295043492

    Patients

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