BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS MEN BEARING UHMWPE LARGE SZ 4

    MDR report key: 4173548 · Received October 15, 2014

    Report

    Report Number
    3002806535-2014-00233
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    November 24, 2014
    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 OXFORD MENISCAL BEARING WAS REVISED AFTER 11 YEARS AND 5 MONTHS DUE TO ¿BEARING WEAR¿. IT IS REPORTED THAT THE PATIENT FELL AND THE BEARING DISLODGED MEDIALLY, HOWEVER THE DATE OF THE FALL HAS NOT BEEN REPORTED HENCE IT IS UNKNOWN HOW LONG THE BEARING WAS FUNCTIONING IN THIS LOCATION. THE SEVERE DEFORMATION ON THE MEDIAL SIDE OF THE INFERIOR ARTICULATING SURFACE SUGGESTS THAT THE MENISCAL BEARING WAS OVERHANGING THE TIBIAL TRAY PRIOR TO REVISION. THE LATERAL SIDE OF THE SUPERIOR ARTICULATING SURFACE EXHIBITS SEVERE DELAMINATION AND DISCOLORATION WHICH MAY BE INDICATIVE OF FEMORAL IMPINGEMENT. BOTH THE INFERIOR AND SUPERIOR ARTICULATING SURFACES EXHIBIT A LARGE NUMBER OF INDENTATIONS WHICH SUGGESTS THAT THIRD BODY WEAR ALSO MAY HAVE OCCURRED. THE POTENTIAL FEMORAL EDGE WEAR AND POSSIBLE SOURCE OF THIRD BODY PARTICLES CANNOT BE CONFIRMED WITHOUT RADIOGRAPHIC IMAGES. AN ASSESSMENT OF THE POSITIONING, SIZING AND ALIGNMENT OF THE BEARING IS ALSO UNABLE TO BE MADE. THEREFORE, THE ULTIMATE CAUSE FOR THE ADVERSE BEARING WEAR CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 RETURN OF ITEM AND COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REPLACEMENT SURGERY ON (B)(6), 2003. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2014 DUE TO BEARING WEAR. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653644 OXFORD PKS MEN BEARING UHMWPE LARGE SZ 4 PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 566506

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R