BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF PKS ANAT MEN BRG UHMWPE RT MED SZ 3

    MDR report key: 2883396 · Received December 21, 2012

    Report

    Report Number
    3002806535-2012-00376
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 29, 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 EXPLANTS WERE RETURNED TO BIOMET UK FOR EVALUATION HOWEVER A FULL INVESTIGATION WAS NOT DEEMED NECESSARY AS THE SURGEON REVISED THE IMPLANTS DUE TO "INAPPROPRIATE IMPLANT FOR PATIENT ANATOMY."

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. ITEM IS TO BE RETURNED. UPON ITEM RETURN AND COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE REPLACEMENT ON (B)(6) 2011. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO 'INAPPROPRIATE IMPLANT FOR PATIENT ANATOMY'. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXF PKS ANAT MEN BRG UHMWPE RT MED SZ 3 OXFORD ANATOMIC BEARING NRA BIOMET UK LTD. N/A 2189513

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R