BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN BOX FEMORAL

    MDR report key: 7291815 · Received February 23, 2018

    Report

    Report Number
    0001825034-2018-00897
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    November 8, 2013
    Report Date
    May 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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 · 1

    (B)(6). MEDICAL PRODUCTS: BIOMET CC I-BEAM TRAY CAT#: 141221, LOT#: J2869149; BIOMET SERIES THIN PATELLA CAT #: 184784, LOT#: 333330; VANGUARD PS TIBIAL BEARING CAT#: 183628, LOT#: 057300. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00897, 0001825034 - 2018 - 00898, 0001825034 - 2018 - 00900, 0001825034 - 2018 - 00901. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE PRODUCT WAS EVALUATED THROUGH A MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE OPERATIVE NOTES FROM THE INITIAL PROCEDURE INDICATE THAT DURING IMPACTION OF THE CEMENTED UNICOMPARTMENTAL KNEE TIBIAL COMPONENT, A LONGITUDINAL SPLIT WAS NOTED, RENDERING THE TIBIAL PLATEAU UNSTABLE. THE COMPONENTS WERE REMOVED AND TOTAL KNEE REPLACEMENT WAS ELECTED TO BE PERFORMED. AT THE CONCLUSION OF THE PROCEDURE THE WOUND WAS STABLE AND FULL FLEXION AND FULL EXTENSION WAS ACCOMPLISHED. ADDITIONAL NOTES PROVIDED CONFIRM THAT THE PATIENT DEVELOPED STIFFNESS THAT DID NOT IMPROVE, THUS ARTHROSCOPY WITH LYSIS OF ADHESIONS AND MANIPULATION UNDER ANESTHESIA WAS PERFORMED. INITIALLY RANGE OF MOTION WAS 5 TO 80 DEGREES AND THE PATELLA DEMONSTRATED LIMITED MOBILITY. FOLLOWING LYSIS OF ADHESIONS RANGE OF MOTION FROM 0 TO 120 WAS ACHIEVED AND THERE WAS INCREASED PATELLAR MOBILITY MEDIALLY AND LATERALLY TO NORMAL PARAMETERS. KNEE JOINT HEMOSTASIS WAS STATED TO BE FULLY MAINTAINED. A RADIOGRAPHIC REVIEW INDICATED NO EVIDENCE OF ACUTE FRACTURE, DISPLACEMENT, LOOSENING OR BONE DESTRUCTION. THE REVIEW CONCLUDED THAT THE OVERALL FIT, SIZE AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE AND THAT THE IMPLANTS ARE APPROPRIATE SIZE FOR PATIENT ANATOMY. NO GROSS ABNORMAL LESIONS WERE SEEN AND THERE WERE NO SIGNS OF LOOSENING OR RADIOLUCENCY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. 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 PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY AND HAS BEEN EXPERIENCING PAIN AND SWELLING ONGOING SINCE THE PROCEDURE. SUBSEQUENTLY THE PATIENT HAD AN ARTHROSCOPIC LEFT KNEE PROCEDURE DURING WHICH LYSIS OF ADHESIONS, MANIPULATION UNDER ANESTESIA, AND EXTENSIVE PARTIAL SYNOVECTOMY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS BEEN EXPERIENCING PAIN AND SWELLING ONGOING AFTER LEFT TOTAL KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134702 VANGUARD PS OPEN BOX FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 059820 

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R