BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 7.5MM OFFSET ADAPTER

    MDR report key: 9616324 · Received January 22, 2020

    Report

    Report Number
    0001825034-2020-00364
    Event Type
    Injury
    Date Received
    January 22, 2020
    Report Date
    January 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304483019
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 148291 - BMT SPLINED KNEE STM V2 16X40 ¿ 999910, 141355 - RGX 3 PEG SER A PATELLA 28MM ¿ 528570, 148301 - BMT SPLINED KNEE STM V2 11X80 ¿ 739010, 183808 - VNGD SSK PSC TIB BRG SM 18X59 ¿ 546740, 185536 - VG 360 OTI TIB SLV SM HALF B ¿ 602200, CP116182 - TI P AUG 57.5 RT 360 FMRL ¿ 117060, 185212 - BMT 360 7.5MM OFFSET ADAPTER - 947060, CP116184 - CUS TI POR 59 360 TIB TRAY - 117070. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, IT WAS CONFIRMED A SCREW FOR THE OFFSET ADAPTER CONTAINS NICKEL. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 02013, 0001825034 - 2019 - 02014, 0001825034 - 2019 - 02015, 0001825034 - 2019 - 02016, 0001825034 - 2019 - 02017, 0001825034 - 2019 - 02018, 0001825034 - 2019 - 02019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING PAIN, BURNING, AND DIFFICULTY AMBULATING APPROXIMATELY 3 YEARS AFTER KNEE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79849 BMT 360 7.5MM OFFSET ADAPTER PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 947060 00880304483019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other