BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD ANT STBLZD BRG 10X79

    MDR report key: 10678624 · Received October 14, 2020

    Report

    Report Number
    0001825034-2020-03786
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    August 27, 2020
    Report Date
    November 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304437159
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED 70 YEAR OLD MALE PARTICIPATING IN CLINICAL STUDY, UNDERWENT PRIMARY RIGHT UNILATERAL TKA ON 01 (B)(6) 2020 AND SUBSEQUENTLY WAS EXPERIENCING STIFFNESS OF JOINT DUE TO ARTHROFIBROSIS. A MUA (MANIPULATION UNDER ANESTHESIA) WAS PERFORMED ON (B)(6) 2020. ARTHROFIBROSIS IS DEFINED AS THE DEVELOPMENT OF FIBROUS TISSUE OR SCAR TISSUE IN A JOINT. ARTHROFIBROSIS IS A KNOWN POSTOPERATIVE PROCEDURE RELATED COMPLICATION THAT CAN OCCUR FROM NOT ONLY SURGICAL IMPLANTATION OF NEW JOINT, BUT ALSO PREVIOUS INJURIES TO THE JOINT, OR SURGICAL PROCEDURES. AS JOINT TRAUMA, INJURY OR SURGICAL PROCEDURES INCREASE THE RISK FOR DEVELOPMENT OF THESE FIBROSIS OR SCAR TISSUE FORMATION, THUS CAUSING CONTRACTURE OF THE TISSUE. THIS RESULTS IN THE PATIENT HAVING INCREASE SYMPTOMS OF PAIN, LIMP, WEAKNESS, SWELLING, AND INABILITY TO HAVE FULL RANGE OF MOTION. SYMPTOMS CAN DEPEND ON THE LOCATION OF THE ARTHROFIBROSIS TISSUE. IF THIS DEVELOPS, CONSERVATIVE MEASURES WOULD BE ATTEMPTED FIRST, SUCH AS MUA OR THERAPY. IF CONSERVATIVE MEASURES FAIL, SURGICAL INTERVENTION COULD BECOME NECESSARY TO REMOVE THE FIBROUS TISSUE CAUSING THE PROBLEMS. IT WAS REPORTED THE PATIENT UNDERWENT MANIPULATION OF THE JOINT. 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. PATIENT HAD INCREASE RISK FOR DEVELOPING SCAR TISSUE DUE TO THE RECENT SURGICAL PROCEDURE. PATIENT REMAINS IMPLANTED TO DATE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03785, AND 0001825034-2020-03787. D11 MEDICAL DEVICES: VANGUARD CR ILOK FEM-RT 70 CATALOG#: 183012 LOT#: J6759703, SERIES A PAT THN 34 3 PEG CATALOG#: 184786 LOT#: 911160, BIOMET CC I-BEAM TRAY 79MM CATALOG#: 141225 LOT#: J6758277. 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 THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO ARTHROFIBROSIS AND STIFFNESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141688 VNGD ANT STBLZD BRG 10X79 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 148240 00880304437159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention