BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT STD 31 3 PEG

    MDR report key: 12216720 · Received July 23, 2021

    Report

    Report Number
    0001825034-2021-02140
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    June 30, 2021
    Report Date
    February 2, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304431317
    PMA / PMN Number
    K040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: VNGD TI FEM CR 62.5MM RT CATALOG # CP113616 LOT # 176190, BIOMET ILOK PRI TIB TRAY 71MM CATALOG # 141213 LOT # 012440, VNGD ANT STAB BRG 13X71 CATALOG # 189063 LOT # 919050. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2021-02136, 0001825034-2021-02138, 0001825034-2021-02139. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO PAIN, STIFFNESS AND ARTHROFIBROSIS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113603 SERIES A PAT STD 31 3 PEG PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 950430 00880304431317

    Patients

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