BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ2.5

    MDR report key: 16822567 · Received April 27, 2023

    Report

    Report Number
    1818910-2023-08810
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 27, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295025771
    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. 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 PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). A-9053408 - APR 21 2023. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON 21 APR 2023 AT 11:20 AM STATING ¿ AFTER DISCUSSING WITH MY TEAMMATE WHO COVERED THIS CASE, THE CONSTRUCT WAS REVISED FOR INSTABILITY. THAT IS ALL THE ADDITIONAL INFORMATION WE HAVE AT THIS TIME. 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

    IT WAS REPORTED THAT THE PATIENT CAME IN WITH A FAILED TKA. SURGEON, HOSPITAL AND DATE IT WAS IMPLANTED WAS NOT AVAILABLE. THE SURGEON REMOVED A SIGMA PS CONSTRUCT AND REIMPLANTED AN ATTUNE REVISION. THE PATELLA COMPONENT WAS LEFT. DOI: UNKNOWN. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625998 MBT CEM KEEL TIB TRAY SZ2.5 MBT TIBIAL TRAY : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS INC US 1294-33-125 2129433125 10603295025771

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention PFC SIGMARP STB TB IN 3 10.0| UNK KNEE FEMORAL SIGMA PS| UNK KNEE TIBIAL TRAY SIGMA (RP) MBT