BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 TIBIAL TRAY 79MM

    MDR report key: 3903114 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05836
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    February 24, 2014
    Report Date
    January 27, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 3 OF 12 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05835/05845).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES FOR REVISION SURGERY ((B)(6) 2014): IT WAS NOTED THAT THE PATIENT'S INFLAMMATORY MARKS WERE SLIGHTLY ELEVATED AND CONFIRMED THE INFECTION. THE CLEAR JOINT FLUID WAS OBTAINED AND THE CELL COUNT WAS FOUND TO BE 75. A STANDARD PARAPATELLAR ARTHROTOMY WAS PERFORMED, ALL THE IMPLANTS WERE REMOVED AND SPACER MOLDS WERE PLACED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE REMAINS UNDETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2011. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 FOR AN UNKNOWN REASON AND A TOTAL KNEE WAS IMPLANTED. A SUBSEQUENT REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO INFECTION AND ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS. THE PATIENT WAS REIMPLANTED WITH ANOTHER TOTAL KNEE SYSTEM ON (B)(6) 2013. ANOTHER REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 TO REMOVE AND REPLACE ALL COMPONENTS WITH CEMENT SPACER MOLDS DUE TO RECURRENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380462 BMT 360 TIBIAL TRAY 79MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 271430

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R