BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 60

    MDR report key: 12041528 · Received June 22, 2021

    Report

    Report Number
    0001825034-2021-01858
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    February 3, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304270374
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10-MEDICAL PRODUCT VGD CRUC RET TIB BRG 13X63/67, ITEM#: 183423, LOT#: 120010. BIOMET CC I-BEAM TRAY 67MM, ITEM#: 141222, LOT#: J6949402. SERIES A PAT STD 31 3 PEG, ITEM#: 184764, LOT#: 950440. ACCORDING TO TABERS MEDICAL DICTIONARY, MANIPULATION OF A JOINT IS A MOBILIZATION TECHNIQUE, SOMETIMES INVOLVING A RAPID THRUST OR STRETCHING OF A JOINT, WITH OR WITHOUT ANESTHESIA. WITH ANESTHESIA IS (MUA). PER CLINICAL ORTHROPAEDICS AND RELATED RESEARCH (HOW TO TREAT THE STIFF TOTAL KNEE ARTHROPLASTY? A SYSTEMATIC REVIEW), MUA IS USED TO TREAT AND RESOLVE ARTHROFIBROSIS (SCAR TISSUE). THIS PROCEDURE IS PERFORMED TO INCREASE ARTICULAR MOTION AND REDUCE CHRONIC PAIN FROM ARTHROFIBROSIS. THE INDICATION FOR MANIPULATION UNDER ANESTHESIA IS RELATED TO LIMITED RANGE OF MOTION AND STIFFNESS DUE TO ADHESIONS/SCAR TISSUE. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION PROVIDED DOES NOT ALTER PREVIOUSLY REPORTED INVESTIGATION RESULTS. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REFERENCE REPORT: 0001825034-2021-01842.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WAS PERFORMED EARLY 2021. SUBSEQUENTLY, THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA A MONTH LATER DUE TO ARTHROFIBROSIS. ATTEMPTS HAVE BEEN MADE, BUT NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940908 VANGUARD CR ILOK FEM-RT 60 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6952229 00880304270374

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other