BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM PS TIBIAL BEARING

    MDR report key: 7002271 · Received November 5, 2017

    Report

    Report Number
    0001825034-2017-09887
    Event Type
    Injury
    Date Received
    November 5, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - VAN PS CLSD INTLK FEM-RT 65 CATALOG #: 183208 LOT #: 774540, BIOMET CC I-BEAM TRAY 71 MM CATALOG #: 141223 LOT #: 746160, AND BMET ARCOM AP PAT 3PST 31 MM SM CATALOG #: 11-150840 LOT #: 825000.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. ON THE CROSSTABLE LATERAL X-RAY, THERE APPEARS TO BE FLEXED ALIGNMENT OF THE FEMORAL COMPONENT WHICH MAY BE ASSOCIATED WITH PROBLEMS SUCH AS FLEXION CONTRACTURE, INCREASED FEMOROTIBIAL WEAR AND INCREASED STRESS ON PATELLAR COMPONENT. THIS CONFIRMS THE INSTABILITY IN THE KNEE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- UNKNOWN VANGUARD FEMUR, UNKNOWN VANGUARD TIBIAL TRAY. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWELVE YEARS POST-IMPLANTATION DUE TO INSTABILITY. THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BEARING REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781531 VANGUARD DCM PS TIBIAL BEARING PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 586920

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R