BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN INTL FEM-RT 67.5 67.5

    MDR report key: 9616197 · Received January 22, 2020

    Report

    Report Number
    0001825034-2020-00369
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    January 10, 2020
    Report Date
    February 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW DETERMINED ANATOMIC ALIGNMENT OF THE RIGHT KNEE ARTHROPLASTY. BONE IS OSTEOPENIC. NO RADIOGRAPHIC ABNORMALITIES FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE HOSPITAL WILL NOT PERMIT THE RETURN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 183720 LOT # 220940, ITEM # 185650 LOT # 392980, ITEM # 184764 LOT # 292520, ITEM # 148144 LOT # 259260, ITEM # 185202 LOT # UNKNOWN, ITEM # 183099 LOT # 810770, ITEM # 183110 LOT # 476500. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00368.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TKA; SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PERSISTENT AND CONSTANT STIFFNESS APPROXIMATELY TWO YEARS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81551 VANGUARD PS OPEN INTL FEM-RT 67.5 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 476500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R