BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC V2 INTERLOK TIB 12X 75MM

    MDR report key: 2802714 · Received October 24, 2012

    Report

    Report Number
    3002806535-2012-00317
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA THIS IS 2 OF 2 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDR 3002806535-2012-00316.

    Additional Manufacturer Narrative · 1

    THE REVISION WAS PERFORMED DUE TO INFECTION. STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATION. FROM ASSESSMENT OF BOTH THE RETURNED COMPONENTS AND THE RADIOGRAPHS, THERE ARE GOOD INDICATIONS OF LOOSENING - BURNISHING, RADIOLUCENCY, GAPS, WEAR MARKS. THE CEMENT MANTLE ON BOTH THE FEMORAL AND TIBIAL IMPLANTS HAS SOME OVERHANG IN AREAS. ALTHOUGH THERE IS EVIDENCE OF GOOD BONE INTERDIGITATION ON BOTH, THERE ARE SOME SMALL REGIONS IN WHICH THE CEMENT MAY HAVE EITHER BEEN TOO THIN, OR HAVE STARTED TO CURE PRIOR TO POSITIONING ON THE RESECTED BONE. THE OVERHANGING CEMENT OR POSSIBLE OSTEOPHYTES ON THE PATELLA COULD HAVE BEEN THE CAUSE FOR WHAT APPEARS TO BE THIRD BODY DEBRIS AND HENCE THE SCRATCHING AND PITTING ON THE POLYETHYLENE ARTICULATING SURFACE. WHILE THE EXACT CAUSE OF THE INFECTION IS UNCLEAR, IT IS NOT THOUGHT TO BE RELATED TO THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE SURGERY ON (B)(6) 2010. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO INFECTION. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGC V2 INTERLOK TIB 12X 75MM AGC V2 INTERLOK TIBIAL JWH BIOMET UK LTD. N/A 1558624

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R