BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65

    MDR report key: 6508493 · Received April 20, 2017

    Report

    Report Number
    3002806535-2017-00232
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    March 22, 2017
    Report Date
    December 13, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - VANGUARD CR LIP TIBIAL BEARING 10X63/67, CATALOG #: 183520, LOT #: 074450; SERIES A 3 PEG STANDARD 28X8, CATALOG #: 184762, LOT #: 977440; POLISHED FINNED TIBIAL TRAY 67 MM, CATALOG # 141252, LOT #: 2015080174. (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET UK AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET UK MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER K023546. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-02692.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO INSTABILITY AND FEMORAL LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290897 VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65 PROTHESIS, KNEE JWH BIOMET UK LTD. 3476277

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R