BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM CEMENTLESS RIGHT MEDIAL TIBIAL TRAY SIZE C WITH SLOTS

    MDR report key: 5987951 · Received September 29, 2016

    Report

    Report Number
    3002806535-2016-00770
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    August 31, 2016
    Report Date
    September 2, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 19 STATES, "PERSISTENT PAIN." 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 PMA NUMBER P010014.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT REVISION PROCEDURE APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO PAIN AND MEDIAL CONDYLE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639999 OXFORD PARTIAL KNEE SYSTEM CEMENTLESS RIGHT MEDIAL TIBIAL TRAY SIZE C WITH SLOTS PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 3704315

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R