BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED VANGUARD DCM TIBIAL BEARING

    MDR report key: 6415147 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01721
    Event Type
    Injury
    Date Received
    March 17, 2017
    Report Date
    April 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS - SERIES A PATELLA CATALOG 184768 LOT 273260; OFFSET TAPE ADAPTER CATALOG 185211 LOT 192780; SPLINED KNEE STEM CATALOG 141624 LOT 858380; SPLINED KNEE STEM CATALOG 141618 LOT 984430; BIOMET TIBIAL TRAY CATALOG 185203 LOT 162630; VANGUARD SSK FEMUR CATALOG 185267 LOT 2745024. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS 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

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE EXPLANT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE REVISION DUE TO INSTABILITY APPROXIMATELY TWO YEARS POST IMPLANTATION; THE BEARING AND LOCKING BAR WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION OF A TIBIAL BEARING DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195204 CONSTRAINED VANGUARD DCM TIBIAL BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 991810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R