BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD AS TIB BRG 10X63

    MDR report key: 12771634 · Received November 8, 2021

    Report

    Report Number
    0001825034-2021-03060
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    February 16, 2021
    Report Date
    December 20, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304466005
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE PATIENT WAS ALSO NOTED TO HAVE A MUA PRIOR TO REVISION AND WAS NOTED TO HAVE EXCESSIVE POLY WEAR IDENTIFIED DURING REVISION SURGERY. THE PATIENT WAS ALSO NOTED TO HAVE ADHESIONS CAUSING A LIMITATION IN FLEXION AS WELL AS INSTABILITY CAUSED BY DETERIORATION OF THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED FOR THE WEAR. INVESTIGATION RESULTS CONCLUDED THAT THE ADHESIONS AND INSTABILITY WERE DETERMINED TO BE UNRELATED TO THE DEVICE. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: VANGUARD CR POR FMRL-LT 60: CATALOG#:183064, LOT#:438740; BIOMET CC CRUCIATE TRAY 63MM: CATALOG#:141231, LOT#:J6028301; SERIES A PAT W/WR STD 25 1 PEG: CATALOG#:184700, LOT#:439010. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-03061, 0001825034-2021-03062. CUSTOMER HAS INDICATED THAT PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT HAS BEEN DISCARDED. 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 TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. THE PATIENT THEN UNDERWENT A KNEE MANIPULATION UNDER ANESTHESIA SIX MONTHS LATER FOR ARTHROFIBROSIS. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY THREE YEARS POST INITIAL IMPLANTATION DUE TO PAIN, SWELLING, STIFFNESS, AND DIFFICULTY WALKING. DURING THE REVISION, ARTHROFIBROSIS, MCL AND PCL LEADING TO INSTABILITY, AND POLYETHYLENE WEAR WERE NOTED. THE TIBIAL COMPONENT, FEMORAL COMPONENT, AND ARTICULAR SURFACE WERE EXCHANGED WITHOUT DIFFICULTY. THE PATELLAR COMPONENT REMAINED INTACT AND WELL FIXED AND WAS NOT REVISED. AT 3 AND 6 MONTH POST OP VISIT PATIENT HAD INJECTIONS FOR BURSITIS AND TENDINITIS, TREATED WITH MEDICATIONS AND COMPRESSION SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667975 E1 VNGD AS TIB BRG 10X63 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. EP-189020 380410 00880304466005

    Patients

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