BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ2

    MDR report key: 9922120 · Received April 3, 2020

    Report

    Report Number
    1818910-2020-10139
    Event Type
    Injury
    Date Received
    April 3, 2020
    Date of Event
    March 17, 2020
    Report Date
    March 17, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295025764
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. 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.

    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

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 VIA TKA FOR THE PATIENT¿S LEFT KNEE. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE FEMORAL COMPONENT (P/N: 950012), THE TIBIAL INSERT (P/N: 951020) AND THE TIBIAL TRAY (P/N: 129433120) DUE TO LOOSENING. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387334 MBT CEM KEEL TIB TRAY SZ2 MBT TIBIAL TRAY : KNEE TIBIAL TRAY NJL DEPUY ORTHOPAEDICS INC US 1294-33-120 2978079 10603295025764

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PFC SIG RPF CEM FEM SZ 2 LT| PFC SIG RPF INS SZ 2 10MM| UNKNOWN BONE CEMENT