BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK 360 FEMUR L 62.5

    MDR report key: 8471925 · Received April 1, 2019

    Report

    Report Number
    0001825034-2019-01192
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    August 6, 2014
    Report Date
    November 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    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 · 0

    THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND MEDICAL RECORDS, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. THE PAIN WAS LIKELY CAUSED BY THE PATIENT'S PES BERSITIS, HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01191 - 1, 0001825034 - 2019 - 01222 - 1, 0001825034 - 2019 - 01221 - 1, 0001825034 - 2019 - 01223 - 1, 0001825034 - 2019 - 01224 - 1, 0001825034 - 2019 - 01225 - 1, 0001825034 - 2019 - 01226 - 1, 0001825034 - 2019 - 01227 - 1, 0001825034 - 2019 - 01228 - 1, 0001825034 - 2019 - 01229 - 1, 0001825034 - 2019 - 01230 - 1.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT HAD CONTINUED PAIN DUE TO PES BURSITIS APPROXIMATELY ONE YEAR POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD SSK PSC TIB BRG; P/N: 183866, L/N: 017260, VNGD SSK 360 FEMUR; P/N: 185283, L/N: 2904032, VG 360 UNIV PST FM AUG; P/N: 185423, L/N: 766730, VG360 DST FM AG; P/N: 185303, L/N: 072920, VG 360 DST FM AG; P/N: 185403, L/N: 595180, BMT SPLINED KNEE STM; P/N: 148306, L/N: 322210, BMT 360 TIB 5.0 OFFSET; P/N: 185211, L/N: 343790, BMT 360 TIB TRAY; P/N: 185202, L/N: 334640, BMT SPLINED KNEE STM; P/N: 148303, L/N: 101240, BMT 360 2.5MM OFFSET; P/N: 185210, L/N: 918030, BMT 360 TIB AUG; P/N: 185222, L/N: 393480, BMT 360 TIB SM CRUCIATE; P/N: 185650, L/N: 342260. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01191, 0001825034 - 2019 - 01192, 0001825034 - 2019 - 01222, 0001825034 - 2019 - 01221, 0001825034 - 2019 - 01223, 0001825034 - 2019 - 01224,, 0001825034 - 2019 - 01225 0001825034 - 2019 - 01226, 0001825034 - 2019 - 01227, 0001825034 - 2019 - 01228, 0001825034 - 2019 - 01229, 0001825034 - 2019 - 01230. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD CONTINUED PAIN DUE TO DECREASED RANGE OF MOTION APPROXIMATELY ONE YEAR POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261985 VNGD SSK 360 FEMUR L 62.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 2904032

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other