BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE FEMORAL SIGMA PS

    MDR report key: 16822569 · Received April 27, 2023

    Report

    Report Number
    1818910-2023-08811
    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
    JWH
    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: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. A-9053408 - (B)(6) 2023 ADDITIONAL INFORMATION RECEIVED FROM JON MARSH ([email protected]) ON (B)(6) 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
    1626000 UNK KNEE FEMORAL SIGMA PS FEMORAL  JWH DEPUY ORTHOPAEDICS INC US

    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