BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 65

    MDR report key: 11701627 · Received April 21, 2021

    Report

    Report Number
    0001825034-2021-01199
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    December 9, 2019
    Report Date
    May 26, 2021
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: NO COMPLICATION NOTED DURING THE INITIAL SURGERY. PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND UNSTABLE KNEE. DURING THE SURGERY, FEMORAL COMPONENT WAS WELL FIXED. HOWEVER, THE TIBIAL PLATE NOTED TO HAVE INCREASED SLOPE AND NO CEMENT WAS NOTED IN THE COMPONENT. PATELLA TRACKING NOTED TO NORMAL. NO OTHER COMPLICATION WAS NOTED DURING THE SURGERY. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 189064 - BEARING - 060240. 141233 - TIBIAL COMPONENT - 540400. 402283 - COBALT BONE CEMENT - 810300. 402283 - COBALT BONE CEMENT - 952670. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE 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: 0001825034-2021-01198, 0001825034-2021-01201.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY LEFT TKA PERFORMED. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 11 YEARS POST IMPLANTATION DUE TO LOOSENING, PAIN, INSTABILITY AND MALPOSITION. IT WAS NOTED THAT THERE WAS NO CEMENT ATTACHED TO THE TIBIAL COMPONENT WHEN IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597214 VANGUARD CR ILOK FEM-LT 65 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 756020

    Patients

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