BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 60

    MDR report key: 10579463 · Received September 24, 2020

    Report

    Report Number
    0001825034-2020-03609
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    August 24, 2020
    Report Date
    December 10, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ONE MONTH FOLLOW-UP - FULL WEIGHT BEARING WITH ANTALGIC GAIT. DIFFUSE PAIN. NORMAL LAXITY AND ALIGNMENT. ROM 10-100. MODERATE PAIN WITH A HEALTH SCORE 75. TWO-MONTHS POST OP - STIFFNESS RESULTING IN MUA (ANKYLOSIS OF RIGHT KNEE). THE ROOT CAUSE OF THE REPORTED ISSUE IS DETERMINED TO BE RELATED TO THE PROCEDURE. 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 DEVICES: 189062 - VNGD ANT STBLZD BRG 12X71 - 954290; 141223 - BIOMET CC I-BEAM TRAY 71MM - J6759983; 184766 - SERIES A PAT STD 34 3 PEG - 364600. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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: 0001825034-2020-03610.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY 6 WEEKS POST IMPLANTATION DUE TO ANKYLOSIS OF RIGHT KNEE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043626 VANGUARD CR ILOK FEM-RT 60 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6734480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R