BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIBIAL TRAY 75MM

    MDR report key: 6697845 · Received July 10, 2017

    Report

    Report Number
    0009610576-2017-00027
    Event Type
    Injury
    Date Received
    July 10, 2017
    Date of Event
    October 21, 2016
    Report Date
    July 10, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER - (B)(4). CONCOMITANT MEDICAL PRODUCTS - VAN PS OPEN INTL FEM-LT 62.5, CATALOG #: 183126, LOT #: J363265. BIOMET BONE CEMENT 1X40G, CATALOG #: 3035890011, LOT #: A511AL1502 AND VNGD PS TIB BRG 10X71/75MM, CATALOG #: 183640, LOT #: 464320. REPORT SOURCE - (B)(6). PMA 510(K): 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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510K NUMBER K915132. THE DEVICE HAS 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHT MONTHS POST-IMPLANTATION DUE TO THE LOCKING BAR BACKING OUT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478274 POLISHED FINNED TIBIAL TRAY 75MM PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. 2015110911

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R