BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ5

    MDR report key: 9197521 · Received October 16, 2019

    Report

    Report Number
    1818910-2019-110128
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    September 21, 2019
    Report Date
    September 25, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295025801
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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.  H10 ADDITIONAL NARRATIVE:  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

    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. PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    MEDICAL RECORDS ((B)(4) MEDICAL RECORDS AD (B)(6) 2019) REVIEWED. CT SCAN OF THE LEFT KNEE WITH 3D RECONSTRUCTION OCCURRED ON (B)(6) 2019. THERE WAS NO EVIDENCE OF BONE FRACTURE. THERE WAS EVIDENCE OF POSSIBLE LINEAR LUCENCY AT THE UNDERSURFACE OF THE MEDIAL TIBIAL TRAY, BETWEEN THE TIBIAL IMPLANT AND THE CEMENT. THERE IS ADDITIONAL LUCENCY BETWEEN THE BONE AND CEMENT MANTLE, APPEARANCE CONSISTENT WITH OSTEOLYSIS. LESS CLEAR WAS EVIDENCE AT THE FAR LATERAL BOUNDARY OF THE TRAY FOR OSTEOLYSIS. THERE WAS NO EVIDENCE OF LUCENCY OR OSTEOLYSIS ASSOCIATED WITH THE FEMUR OR PATELLAR COMPONENTS. THERE WAS EVIDENCE OF A LARGE KNEE JOINT EFFUSION DISTENDING THE SUPRAPATELLAR BURSA, WITH SOFT TISSUE EDEMA IN THE PROXIMAL KNEE. CULTURES: DIRECT GRAM STAIN RECEIVED ON (B)(6) 2019 REVEALED MODERATE POLYMORPHONUCLEAR LEUKOCYTES, HEAVY RED BLOOD CELLS, AND NO ORGANISMS OBSERVED. GRAM POSITIVE COCCI IN CLUSTERS SEEN IN BROTH MEDIA GRAM STAIN ONLY. WBCS 11.1 ELEVATED. RED CELL DISTRIBUTION WIDTH CV 17.6 ELEVATED. NEUTROPHILS ABSOLUTE 7.9 ELEVATED. MONOCYTES ABSOLUTE 1.3 ELEVATED. D-DIMER 1450 NG/ML ELEVATED. ON (B)(6) 2019: SYNOVASURE ALPHA DEFENSIN PJI LDT - POSITIVE : ABNORMAL. ALPHA DEFENSIN S-SF: POSITIVE ABNORMAL. HEMOGLOBIN SF: ELEVATED. CRP-SF: 29.0. THE NEW INFORMATION PROVIDED BY THESE MEDICAL RECORDS SUPPORTS THE DIAGNOSIS OF A POSSIBLE INFECTION. THERE WAS NO REPORTED TREATMENT INTERVENTION HAVING OCCURRED IN THESE RECORDS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF REVISION: (B)(6) 2019; (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994489 MBT CEM KEEL TIB TRAY SZ5 MBT TIBIAL TRAY : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS INC US 8979680 10603295025801

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention