BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD FEMORAL COMPONENT

    MDR report key: 19515136 · Received June 11, 2024

    Report

    Report Number
    0001825034-2024-01551
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    February 20, 2013
    Report Date
    September 24, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, H9, H11. 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 - MEDICAL PRODUCT: UNK VANGUARD FEMORAL COMPONENT, CATALOG #: UNK, LOT #: UNK. E1 VNGD PS TIB BRG 63/67X10, CATALOG #: EP-183620, LOT #: 181130. UNK VANGUARD TIBIAL COMPONENT, CATALOG #: UNK, LOT #: UNK. SERIES A PAT W/WR STD 25 1 PEG, CATALOG #: 184700, LOT #: UNK. 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.

    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 TWO MONTHS POST IMPLANTATION DUE TO ARTHROFIBROSIS AND DECREASED RANGE OF MOTION. NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197489 UNKNOWN VANGUARD FEMORAL COMPONENT PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

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