BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 7.5MM OFFSET ADAPTER

    MDR report key: 5747741 · Received June 24, 2016

    Report

    Report Number
    0001825034-2016-02245
    Event Type
    Injury
    Date Received
    June 24, 2016
    Date of Event
    May 25, 2016
    Report Date
    March 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02244 / 02245).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - TIBIAL TRAY - CATALOGUE: 185204 LOT: 795630. FEMUR - CATALOGUE: 185286 LOT: 2372149. TIBIAL OFFSET - CATALOGUE: 185211 LOT: 406560. STEM - CATALOGUE: 148322 LOT: 025650. DISTAL FEMORAL AUGMENT - CATALOGUE: 185486 LOT 767180. DISTAL FEMORAL AUGMENT - CATALOGUE: 185466 LOT 767290. UNIVERSAL FEMORAL AUGMENT - CATALOGUE: 185426 LOT: 020330. UNIVERSAL FEMORAL AUGMENT - CATALOGUE: 185426 LOT: 874820. STEM - CATALOGUE: 148321 LOT: 078660. TIBIAL CRUCIATE WING - CATALOGUE: 185651 LOT: 537320. TIBIAL AUGMENT - CATALOGUE: 185244 LOT: 698400. TIBIAL AUGMENT - CATALOGUE: 185234 LOT: 303890. TIBIAL BEARING - CATALOGUE: 183884 LOT: 804110. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF COMPONENTS DETERMINED THAT THE FEMORAL STEM SHOWS A FRACTURE THAT IS SHEARED OFF AT AN ANGLE. BOTH THE TIBIAL AND FEMORAL COMPONENT SHOW A LOT OF BLUE CEMENT BUT NOT A LOT OF BONE ARTIFACTS. THE DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. UPDATED: REPORT CORRECTIONS, ADDITIONAL INFORMATION, EVALUATION. UPDATED EVALUATION CODES: ACTUAL DEVICE EVALUATED, MANUFACTURING REVIEW, VISUAL INSPECTION, PHOTOGRAPHIC INSPECTION, LABELING EVALUATION. UPDATED RESULTS CODES: FRACTURE PROBLEM. UPDATED CONCLUSIONS CODES: OPERATIONAL CONTEXT CAUSE OR CONTRIBUTED TO EVENT. CORRECTED: CORRECTED WITH PATIENT INITIALS. CORRECTED WITH PREVIOUS REVISION HISTORY. CORRECTED REPORTERS LAST NAME.

    Description of Event or Problem · 1

    PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 2 YEARS POST-IMPLANTATION DUE TO LOOSENING. IT WAS NOTED DURING THE PROCEDURE THAT THE OFFSET ADAPTER BETWEEN THE FEMUR AND STEM FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402786 BMT 360 7.5MM OFFSET ADAPTER PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 372480

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R