BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE KNEE TIBIAL INSERT

    MDR report key: 21732156 · Received March 31, 2025

    Report

    Report Number
    1818910-2025-04753
    Event Type
    Injury
    Date Received
    March 31, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY: THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. 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

    REPORT WAS RECEIVED FROM SURGEON REGARDING THE ATTUNE MS INSERT. REPORT INCLUDED 195 KNEES. BELOW ADVERSE EVENTS WERE INCLUDED. PATIENT ID - (B)(6). 77-YEAR-OLD FEMALE. 157CM AND 63 KGS. DOI (B)(6) 2023 UNDERWENT A MUA ON (B)(6) 2025 ON HER LEFT KNEE. IMPLANTS. UNK ATTUNE KNEE PATELLA. UNK ATTUNE KNEE TIBIAL TRAY. UNK ATTUNE FEMORAL COMPONENT. UNK ATTUNE TIBIAL INSERT. UNK BONE CEMENT. PATIENT ID - (B)(6). 59-YEAR-OLD MALE. 177CM AND 98 KGS. DOI (B)(6) 2023 UNDERWENT A MUA ON (B)(6) 2025 ON HIS RIGHT KNEE. IMPLANTS. UNK ATTUNE KNEE PATELLA. UNK ATTUNE KNEE TIBIAL TRAY. UNK ATTUNE FEMORAL COMPONENT. UNK ATTUNE TIBIAL INSERT. UNK BONE CEMENT. PATIENT ID - (B)(6). 64-YEAR-OLD MALE. 185CM AND 90 KGS. DOI (B)(6) 2023 UNDERWENT A MUA ON (B)(6) 2025 ON HIS LEFT KNEE. IMPLANTS. UNK ATTUNE KNEE PATELLA. UNK ATTUNE KNEE TIBIAL TRAY. UNK ATTUNE FEMORAL COMPONENT. UNK ATTUNE TIBIAL INSERT. UNK BONE CEMENT. PATIENT ID - (B)(6). 64-YEAR-OLD MALE. 185CM AND 90 KGS. DOI (B)(6) 2023 UNDERWENT A MUA ON (B)(6) 2025 ON HIS RIGHT KNEE. IMPLANTS. UNK ATTUNE KNEE PATELLA. UNK ATTUNE KNEE TIBIAL TRAY. UNK ATTUNE FEMORAL COMPONENT. UNK ATTUNE TIBIAL INSERT. UNK BONE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010090 UNK ATTUNE KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention