BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 70

    MDR report key: 8439275 · Received March 21, 2019

    Report

    Report Number
    0001825034-2019-01286
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    February 18, 2019
    Report Date
    December 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MEDICAL RECORDS CONFIRMS THE REPORTED EVENT. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE ROOT CAUSE FOR THE REPORTED ISSUES ARE RELATED TO THE PROCEDURE AND ARE NOT ABNORMAL TO THE PROCEDURE. NO FAILURE DETECTED WITH THE DEVICES. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019- 01286, 0001825034-2019-01287, 0001825034-2019-01288, AND 0001825034-2019-01289. CONCOMITANT MEDICAL PRODUCTS: VG CRL MONO-LCK BRG 12X71 CATALOG#: 189262 LOT#: 873920, SERIES A PAT STD 31 3 PEG CATALOG#: 184764 LOT#: 669090, UNKNOWN TIBIAL TRAY CATALOG#: NI LOT#: NI. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. 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 THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT RETURNED TO THE SURGEON'S OFFICE WITH A CONCERN ABOUT A STITCH ABSCESS, AND THEN UNDERWENT AN IRRIGATION AND DEBRIDEMENT ALONG WITH WOUND CLOSURE THE FOLLOWING DAY. NO DEVICES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234557 VANGUARD CR ILOK FEM-RT 70 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R