BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 67.5

    MDR report key: 8651204 · Received May 29, 2019

    Report

    Report Number
    0001825034-2019-02347
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    November 27, 2017
    Report Date
    October 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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. MEDICAL RECORDS WERE REVIEWED AND IDENTIFIED LIMITED FLEXION AND EXTENSION AS WELL AS UNEXPLAINED PAIN AND CONFIRMED THE MANIPULATION UNDER ANESTHESIA. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: VANGUARD TIBIAL BEARING 10X71/75, CATALOG: 183440, LOT: 630980; POLISHED FINNED TIBIAL TRAY 71MM, CATALOG: 141253, LOT: 2014070113; SERIES A PAT STD 31 3 PEG 184764, LOT: 426800. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02348. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY ONE MONTH POST TOTAL KNEE ARTHROPLASTY DUE TO UNEXPLAINED PAIN AND LIMITED RANGE OF MOTION. NO FURTHER INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443541 VANGUARD CR ILOK FEM-LT 67.5 PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A J3953848

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention