BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC3 RP TIBIAL INSERT S2.5,12.5

    MDR report key: 14929680 · Received July 6, 2022

    Report

    Report Number
    1818910-2022-12354
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 21, 2022
    Report Date
    July 6, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295242130
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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.

    Description of Event or Problem · 0

    REVISION OF RIGHT REVISION TOTAL KNEE REPLACEMENT. PFC TC3 RP REVISION PROSTHESIS INSITU. DR. UNDERSTOOD TO HAVE IMPLANTED THE PFC TC3 RP PROSTHESIS AS A REVISION PROSTHESIS. NO KNOWLEDGE OR INFORMATION REGARDING THE ORIGINAL PRIMARY IMPLANT. NO KNOWLEDGE OF ANY PREVIOUS SURGERY DATES OR HOSPITAL WHERE IMPLANTED. ATTEMPTS MADE TO OBTAIN THIS INFORMATION WITHOUT SUCCESS. REVISION FOR STIFFNESS AND PAIN. PROPOSAL TO CONVERT TO AN SROM HINGE PROSTHESIS BY REVISING FEMORAL COMPONENT. THIS WAS ATTEMPTED BUT THE FEMORAL PROSTHESIS WAS UNABLE TO BE EXPLANTED DUE TO THE SIGNIFICANT DEGREE OF ENHANCED FIXATION. THE BEARING WAS EVENTUALLY THE ONLY IMPLANT REVISED AND REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2022. RIGHT KNEE.

    Description of Event or Problem · 0

    1. ARE YOU ABLE TO PROVIDE THE LOT NUMBER OF PRODUCT 962332 (TC3 RP TIBIAL INSERT S2.5,12.5)? NO. 2. WERE THERE ANY ALLEGATIONS AGAINST ANY OTHER OF THE COMPONENTS? UNSURE. 3. WAS THERE A SURGICAL DELAY? IF YES, HOW MANY MINUTES? NOT AS SUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162876 TC3 RP TIBIAL INSERT S2.5,12.5 SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 96-2332 10603295242130

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention MBT REVISION CEM TIB TRAY S2.5| TC3 RP TIBIAL INSERT S2.5,12.5| UNIVERSAL STEM 115X12MM FLUTED| UNIVERSAL STEM 75X10MM FLUTED| UNK KNEE FEMORAL ADAPTOR SIGMA| UNK KNEE FEMORAL SIGMA PS| UNK KNEE PATELLA SIGMA| UNKNOWN KNEE TIBIAL SLEEVE