BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-POROUS PERF TIB TRAY-XSML

    MDR report key: 7365815 · Received March 23, 2018

    Report

    Report Number
    0009610576-2018-00005
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    February 2, 2018
    Report Date
    March 23, 2018
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K915132. PRODUCT HAS BEEN REQUESTED BUT NO INFORMATION HAS BEEN RECEIVED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILLED FOR THE SAME PATIENT (0009610576-2018-00006).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT KNEE REVISION GREATER THAN 10 YEARS POST-IMPLANTATION DUE TO INSTABILITY, WEAR OF THE POLYETHYLENE, AND LOOSENING OF THE SCREW THAT FIXES THE POLYETHYLENE TO THE TIBIAL TRAY. PERIPROSTHETIC OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209381 NON-POROUS PERF TIB TRAY-XSML PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. N/A 2006071005

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R