BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA360 TIBIAL BEARING 63/67X18

    MDR report key: 5774764 · Received July 7, 2016

    Report

    Report Number
    0001825034-2016-02504
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    April 6, 2016
    Report Date
    March 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DATE OF BIRTH - BORN IN 1949. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02450 / 02504). DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCTS - FEMUR - CATALOGUE: 185265 LOT: 3636273. FEMORAL STEM - CATALOGUE: 145024 LOT: 934030. TIBIAL TRAY - CATALOGUE: 161429 LOT: 3582208. TIBIAL STEM - CATALOGUE: 145002 LOT: 378490. TIBIAL OFFSET ADAPTOR - CATALOGUE: 185210 LOT: 827040. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K093293. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE 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. METHODS: MANUFACTURING REVIEW. CONCLUSIONS: UNABLE TO CONFIRM COMPLAINT.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO DIFFICULTY OBTAINING FULL EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428223 VANGUARD DA360 TIBIAL BEARING 63/67X18 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 3217590

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R