BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA 360 O/S TIB TRAY COCR 75

    MDR report key: 12547028 · Received September 29, 2021

    Report

    Report Number
    0001825034-2021-02749
    Event Type
    Injury
    Date Received
    September 29, 2021
    Report Date
    October 11, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, G3, H2, H10. DURING THE INVESTIGATION OF THIS EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DOES NOT FALL WITHIN WARSAW DESIGN CONTROL AND WAS ERRONEOUSLY SUBMITTED UNDER THE INCORRECT MFR NUMBER. THIS EVENT HAS SINCE BEEN REPORTED UNDER THE CORRECT MFR FOR BRIDGEND. PLEASE SEE 3002806535 - 2021 - 00431 FOR REFERENCE. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: VNGD SSK 360 FEMUR L 67.55 CATALOG #: 185285 LOT: 3444874; BMT SMOOTH KNEE STEM 14X80 CATALOG #: 145024 LOT: 304650; VG DA 360 O/S TIB TRAY COCR 75 CATALOG #: 161431 LOT: 3548240; BIOMET SMOOTH KNEE STEMS 10X40 CATALOG #: 145000 LOT: 458990; BMT 360 TIB 5.0 OFFSET ADAPTER CATALOG #: 185211 LOT: 497590; VG DA360 TIB BRG ARCM 71/75X16 CATALOG #: 161449 LOT: 3267971. REPORT SOURCE - FOREIGN: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02747, 0001825034 - 2021 - 02748, 0001825034 - 2021 - 02749, 0001825034 - 2021 - 02750, 0001825034 - 2021 - 02751, 0001825034 - 2021 - 02752. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 3 YEARS POSTOP, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA WITH 48 HOURS OF INPATIENT PHYSICAL THERAPY DUE TO LIMITED FLEXION AND EXTENSION. THE PATIENT CONTINUED TO EXPERIENCED A DECREASE IN RANGE OF MOTION WITH DEBILITATING PAIN AND INABILITY TO PERFORM ADLS. AT THE 7 YEAR FOLLOW UP THE PATIENT STATES THAT DUE TO RHEUMATOID ARTHRITIS THEY ARE ALWAYS IN PAIN AND HAVE DIFFICULTY WALKING AND RISING ETC. BUT THE KNEE NEVER GIVES ANY PROBLEMS WITH PAIN OR MOVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447573 VANGUARD DA 360 O/S TIB TRAY COCR 75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 3548240

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R SEE H10 NARRATIVE.