BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 18874199 · Received March 11, 2024

    Report

    Report Number
    1818910-2024-05515
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 11, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232612
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 960101 , LOT - D21032165 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED 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 LOT : A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 960101 , LOT - D21032165 AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    SUBJECT ID :(B)(6). STUDY NO :(B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: 29 FEB 2024. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL, TIBIAL, INSERT, AND PATELLA WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454311 PFC*SIGMA/OV/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US D21032165 10603295232612

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention DEPUY CMW 1 40G| DEPUY CMW 1 40G| MBT CEM KEEL TIB TRAY SZ2.5| PFC*SIGMA C/R NPOR FE RT SZ2.5| SIG RP AOX CRV INS SZ2.5 10