BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ5

    MDR report key: 8615190 · Received May 16, 2019

    Report

    Report Number
    1818910-2019-93620
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 12, 2019
    Report Date
    April 23, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    UDI-DI
    10603295025801
    PMA / PMN Number
    K943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. 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 WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    SUBJECT ID: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE, FOR MIGRATION/LOOSENING - TIBIAL, FRANK DISRUPTION OF TIBIAL COMPONENT. DOI: (B)(6) 2008; DOR: (B)(6) 2019; (RIGHT KNEE). PRODUCTS PRESENT AT TIME OF REVISION: CATALOG: 129433150; LOT: 2545785; DESCRIPTION: MBT CEMENTED KEEL SZ 5. CATALOG: 960015; LOT: 2495088; DESCRIPTION: SIGMA FEM C/RET CEMENTED RT SZ 5. CATALOG: 960103; LOT: 2545738; DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 41MM. CATALOG: 962052; LOT: 2533501; DESCRIPTION: SIGMA TIBIAL INSERT RP CVD SZ 5 12.5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411181 MBT CEM KEEL TIB TRAY SZ5 MBT TIBIAL TRAY : KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS, INC. 1818910 2545785 10603295025801

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention