BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT SPLINED KNEE STM V2 12X80

    MDR report key: 10140269 · Received June 10, 2020

    Report

    Report Number
    0001825034-2020-02312
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    July 8, 2019
    Report Date
    June 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K121149
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: (B)(6) 2019. 185203 - BMT 360 TIB TRAY - 737710. 185305 - VG 360 DST FM AG - 115520. 183882 - VNGD SSK PSC TIB BRG - 246260. 185650 - BMT 360 TIB SM CRUCIATE - 727430. 148305 - BMT SPLINED KNEE STM V2 - 731620. 185211 - BMT 360 TIB 5.0 OFFSET - 198190. 184764 - SERIES A PAT STD - 693590. 185211 - BMT 360 TIB 5.0 OFFSET - 233860. 185265 - VNGD SSK 360 FEMUR - 3366083. 00111214001 - PALACOS SINGLE - UNKNOWN. 00111214001 - PALACOS SINGLE - UNKNOWN. 00111214001 - PALACOS SINGLE - UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. NO MEDICAL RECORDS WERE PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. PATIENT WAS REVISED WITH NO COMPLICATIONS NOTED. POST-REVISION ULTRASOUND FOUND SOFT TISSUE SWELLING AND TENDINOSIS WITHOUT TEAR. PATIENT CLAIMS TO HAVE TESTED POSITIVE FOR INFECTION BUT CANNOT BE CONFIRMED DUE TO LACK OF MEDICAL RECORDS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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: 0001825034-2019-03370-4. 0001825034-2019-03372-4. 0001825034-2019-03373-4. 0001825034-2019-04217-3. 0001825034-2019-04218-3. 0001825034-2019-04219-3. 0001825034-2019-04233-3. 0001825034-2020-02314. 0001825034-2020-02315.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A REVISION PROCEDURE, THE PATIENT EXPERIENCED PAIN, SWELLING AND FALLING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600820 BMT SPLINED KNEE STM V2 12X80 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 139650

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other