BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT SPLINED KNEE STEM

    MDR report key: 3910963 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05906
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    July 11, 2011
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ 141654; LOT NUMBER - 577620; EXPIRATION DATE ¿ JAN 31, 2021; MANUFACTURE DATE ¿ JAN 26, 2011. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ 141654; LOT NUMBER - 936940; EXPIRATION DATE ¿ MAR 31, 2021; MANUFACTURE DATE ¿ MAR 13, 2011. ADDITIONAL INFORMATION: RADIOGRAPHS TAKEN ON (B)(6) 2011.

    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 ISO 11137-2. THIS MEDWATCH REPORT IS BEING SUBMITTED TO REPORT THE EVENT THAT OCCURRED ON THE RIGHT KNEE. IT IS NOT KNOWN WHICH OF THE FOLLOWING COMPONENTS WERE IMPLANTED IN THE RIGHT KNEE AS THEY WERE IMPLANTED DURING A BILATERAL KNEE PROCEDURE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ 141654, LOT NUMBER - 696660, EXPIRATION DATE ¿ MAR 31, 2021, MANUFACTURE DATE ¿ MAR 6, 2011. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ 141616, LOT NUMBER - 397220, EXPIRATION DATE ¿ JAN 31, 2021, MANUFACTURE DATE ¿ JAN 5, 2011. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ 141654, LOT NUMBER - 577620, EXPIRATION DATE ¿ JAN 31, 2021, MANUFACTURE DATE ¿ JAN 26, 2011. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ 141654, LOT NUMBER - 936940, EXPIRATION DATE ¿ MAR 31, 2021, MANUFACTURE DATE ¿ MAR 13, 2011. 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 5 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05902/05907).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTY PROCEDURES ON UNKNOWN DATES. SUBSEQUENTLY, A BILATERAL REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 TO REMOVE AND REPLACE ALL COMPONENTS DUE TO INFECTION. BIOMET TOTAL KNEES WERE REIMPLANTED ON (B)(6) 2011. IT WAS FURTHER REPORTED THAT A RIGHT KNEE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 WHERE ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS AND A RADICAL DEBRIDEMENT TOOK PLACE DUE TO INFECTION. A FRACTURE ON THE MEDIAL CONDYLE AND A FRACTURE OF THE PROXIMAL TIBIA WERE NOTED DURING THE REVISION PROCEDURE AND THE CONDYLE WAS SECURED WITH K-WIRES. SUBSEQUENTLY, PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386645 BMT SPLINED KNEE STEM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R