BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF PKS ANAT MEN BRG UHMWPE RT SML SZ 3

    MDR report key: 3870667 · Received June 12, 2014

    Report

    Report Number
    3002806535-2014-00147
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    September 4, 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

    AN OXFORD PARTIAL KNEE REPLACEMENT WAS REVISED AFTER APPROXIMATELY ONE YEAR AND NINE MONTHS. THE RETURNED FEMORAL COMPONENT AND TIBIAL TRAY SHOW EVIDENCE OF METAL-ON-METAL CONTACT, WHICH MAY HAVE CONTRIBUTED TO THE METALLOSIS FOUND WITHIN THE JOINT UPON REVISION. IT IS NOT KNOWN HOW THIS METAL-ON-METAL CONTACT MAY HAVE OCCURRED, HOWEVER IT IS POSSIBLE THAT THE MENISCAL BEARING MAY HAVE DISLOCATED AT SOME TIME DURING SERVICE. THE MENISCAL BEARING ITSELF WAS RECEIVED IN GOOD CONDITION WITH VERY FEW SIGNS OF WEAR AND THEREFORE THE MECHANISM OF PROPOSED DISLOCATION IS NOT CLEAR. THE EXACT CAUSE FOR THE PATIENT¿S PAIN AND ULTIMATE CAUSE FOR REVISION CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT OXFORD KNEE SURGERY ON (B)(6) 2012. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO PAIN AND METALLOSIS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347865 OXF PKS ANAT MEN BRG UHMWPE RT SML SZ 3 PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2185341

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R