BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS+ TIB BRG

    MDR report key: 17728573 · Received September 12, 2023

    Report

    Report Number
    0001825034-2023-02147
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    March 23, 2022
    Report Date
    October 10, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304438262
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10. ARTHROFIBROSIS IS DEFINED AS THE DEVELOPMENT OF FIBROUS SCAR TISSUE WITHIN OR SURROUNDING A JOINT. ARTHROFIBROSIS IS A KNOWN POSTOPERATIVE PROCEDURE RELATED COMPLICATION THAT CAN OCCUR FROM SURGICAL IMPLANTATION OF NEW JOINT REPLACEMENT AS WELL AS FROM PREVIOUS INJURIES OR SURGICAL PROCEDURES. SCAR TISSUE FORMATION IS A NORMAL HEALING RESPONSE; HOWEVER, THE BUILDUP OF SUCH CAN RESULT IN PAIN, STIFFNESS, LIMITED RANGE OF MOTION, AND DIFFICULTY PROPERLY AMBULATING. IF EXCESS SCAR TISSUE DEVELOPS, CONSERVATIVE MEASURES SUCH AS EXERCISES OR PHYSICAL THERAPY WOULD BE ATTEMPTED FIRST. IF THESE ATTEMPTS FAIL, SURGICAL INTERVENTION SUCH AS MANIPULATION UNDER ANESTHESIA, ARTHROSCOPIC ARTHROLYSIS, OR OPEN ARTHROTOMY WOULD BECOME NECESSARY TO REMOVE THE FIBROUS TISSUE AND RESTORE JOINT FUNCTION. 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

    (B)(4). D10/D11: CONCOMITANT MEDICAL PRODUCTS - MEDICAL PRODUCT: VAN PS OPEN INTL FEM-RT CATALOG # 183110 LOT # J6638463. BIOMET TIBIAL LOCKING BAR CATALOG # 141205 LOT # 172490. BIOMET CC CRUCIATE TRAY CATALOG # 141233 LOT # J7030162. BIOMET TIBIAL LOCKING BAR CATALOG # 141205 LOT # 305700. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2023-02145. 0001825034-2023-02149. 0001825034-2023-02150. 0001825034-2023-02151. H3 OTHER TEXT : REMAINS IMPLANTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA PROCEDURE FIVE MONTHS POST IMPLANTATION DUE TO PAIN, LIMITED RANGE OF MOTION AND DEPENDENT AMBULATION WITH ASSISTANCE OF A CANE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105017 VNGD PS+ TIB BRG PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 336560 00880304438262

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE