BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS MEN BEARING UHMWPE MED SZ 4

    MDR report key: 2781220 · Received October 10, 2012

    Report

    Report Number
    3002806535-2012-00298
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 11, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THIS IS 2 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. (SEE: 3002806535-2012-00297 / 298).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6) 2000. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO TIBIAL LOOSENING WITH SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD PKS MEN BEARING UHMWPE MED SZ 4 OXFORD TIBIAL BEARING NRA BIOMET UK LTD. N/A 381488

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R