BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC3 RP TIBIAL INSERT S4,10.0

    MDR report key: 10514623 · Received September 10, 2020

    Report

    Report Number
    1818910-2020-19757
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    October 4, 2019
    Report Date
    August 27, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295242345
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : PATIENT PRODUCT X-RAY IMAGES HAVE BEEN PROVIDED FOR REVIEW. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PROVIDED IMAGES ARE JPEG FILES WITHIN PATIENT MEDICAL RECORDS. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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.

    Description of Event or Problem · 0

    ON (B)(6) 2014 THE PATIENT UNDERWENT A MEDIAL UNICOMPARTMENTAL TOTAL KNEE TO ADDRESS THE PREOPERATIVE DIAGNOSIS OF MEDIAL COMPARTMENT OSTEOARTHRITIS, RIGHT KNEE. NO COMPLICATIONS NOTED. MEDICAL RECORDS FROM (B)(6) 2019 NOTED THAT SINCE THE REVISION ON (B)(6) 2016, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING, EFFUSION, AND HAS HAD AN ASPIRATION PERFORMED. SURGEON NOTED A CONCERN FOR LOOSENING OF COMPONENTS, AS WELL AS OSTEOLYSIS VERSUS POSSIBLE INFECTION. RADIOGRAPHS WERE REPORTED TO SHOW POSSIBLE LOOSENING. AT THE TIME OF THIS REVIEW, THERE WERE NO REVISION INFORMATION.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPETITOR SIMPLEX CEMENT X 2 UTILIZED. INFORMATION TOO LARGE TO ADD TO CONCOMITANT SECTION OF THE 3500A 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 · 1

    CLINICAL ADVERSE EVENT RECEIVED FOR LUCENCIES: ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO DEVICE AND PROCEDURE. DATE OF PRIMARY IMPLANTATION: (B)(6) 2014. DATE OF REVISION #1: (B)(6) 2016 (FEMUR, TIBIAL TRAY, INSERT). DATE OF REVISION #2: (B)(6) 2016 (INSERT). DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: KNEE ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979504 TC3 RP TIBIAL INSERT S4,10.0 SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US 96-2351 501351 10603295242345

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention MBT REVISION CEM TIB TRAY SZ 3| MBT TRAY SLEEVE POR M/L 45MM| PFC*SIGMA TC3 FEM RT SZ4| SIGMA FEM ADAPTER 5 DEGREE| SIGMA FEM ADAPTER NEUTRAL BOLT| TC3 RP TIBIAL INSERT S4,10.0| UNIVERSAL FEM SLV DIS POR 46MM| UNIVERSAL STEM 75X12MM FLUTED| UNIVERSAL STEM 75X16MM FLUTED| MBT REVISION CEM TIB TRAY SZ 3| MBT TRAY SLEEVE POR M/L 45 MM| PFC*SIGMA TC3 FEM RT SZ4| SIGMA FEM ADAPTER 5 DEGREE| SIGMA FEM ADAPTER NEUTRAL BOLT| TC3 RP TIBIAL INSERT S4,10.0| UNIVERSAL FEM SLV DIS POR 46 MM| UNIVERSAL STEM 75X12 MM FLUTED| UNIVERSAL STEM 75X16 MM FLUTED