BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC BEARING

    MDR report key: 2481959 · Received March 7, 2012

    Report

    Report Number
    3002806535-2012-00060
    Event Type
    Injury
    Date Received
    March 7, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 10, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    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.EXPIRATION DATE - UNKNOWN.IMPLANT DATE - UNKNOWN.DEVICE EVALUATION IN PROCESS. UPON COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. THIS IS 3 OF 3 MDR REPORTS FILED ON THE SAME EVENT. (REFERENCE 3002806535-2012-00058, 3002806535-2012-00059, AND 3002806535-2012-00060).THIS REPORT FILED (B)(4), 2012.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED TIBIAL COMPONENT EXHIBITS DAMAGE WHICH IS STRONGLY SUGGESTIVE OF LOOSENING WITHIN THE IMPLANTATION SITE. THE CURRENT LACK OF BONE CEMENT MAY SUPPORT THIS SUGGESTION OF LACK OF GOOD FIXATION, ALTHOUGH IT MAY BE THE CASE THAT THE ENTIRE CEMENT MANTLE WAS NOT REMOVED FROM THE SITE OF IMPLANTATION DURING THE EXTRACTION. THE SEVERE DELAMINATION AND PITTING OF THE ARTICULATING SURFACE OF THE POLYETHYLENE BEARING LIKELY CAME ABOUT AS A RESULT OF THIRD BODY WEAR. THE PROTRUDING BONE CEMENT AT THE CENTRAL CUT-OUT IS THE MOST PROBABLE SOURCE OF MATERIAL RESPONSIBLE FOR SUCH DAMAGE AND WITH CORRESPONDING WEAR DAMAGE EVIDENT ON THE LEFT HAND SIDE OF THE TROCHLEAR GROOVE. THE WHITENING AND CRACKING BELOW THE SURFACE OF THE POLYETHYLENE ARE CLEAR INDICATIONS OF OXIDATION OF THE POLYETHYLENE, WHICH MAY HAVE BEEN AS A RESULT OF ELEVATED STRESSES CAUSED BY LARGE THIRD BODY DEBRIS IN THE ARTICULATION. THE SEVERE DAMAGE OF THE TIBIAL COMPONENT OF THE RETURNED PROSTHESIS IS SUGGESTIVE THAT THIRD BODY WEAR AND UNSTABLE FIXATION ARE THE MAIN REASONS FOR THE FAILURE AND IMPLANT REVISION. THE SOURCE OF THE THIRD BODY WEAR MAY HAVE BEEN ONE OF OR A COMBINATION OF OSTEOPHYTES, PROTRUDING BONE CEMENT OR CEMENT DEBRIS. OXIDATION AND DELAMINATION ARE EVIDENT AND INDICATE AN ECCENTRIC WEAR MECHANISM WHICH WOULD HAVE CONTRIBUTED TO THE FAILURE. WITHOUT RADIOGRAPHS AND FURTHER INFORMATION, THE EXACT MODE OF FAILURE CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE PRODUCED ON AN UNKNOWN DATE. REVISION SURGERY WAS PERFORMED ON (B)(6), 2012 DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGC BEARING AGC BEARING JWH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R