BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK BIOINTRAFIX SHEATH

    MDR report key: 3021249 · Received March 26, 2013

    Report

    Report Number
    1221934-2013-00077
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K032167
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT

    Additional Manufacturer Narrative · 1

    ONE HUNDRED-SIXTEEN DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, LITTLE MORE INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. IT IS REPORTED THAT A 2ND PROCEDURE WAS PERFORMED (NO DATE GIVEN) AT WHICH TIME THE UNKNOWN DEVICE WAS REMOVED; SOME UNUSUAL BACTERIUM (?) WAS FOUND IN THE ACL CANAL, THE JOINT WAS CLEANED OUT SEVERAL TIMES AND FLUSHED, ANTIBIOTICS DID NOT HELP. CURRENTLY THEY ARE WAITING FOR THE CANAL TO HEAL AND THEN THEY WILL TREAT WITH DIFFERENT MEDICATIONS (?). THEY ARE WAITING TO TAKE NEW LAB TEST AND DECIDE ON WHAT TO DO. THE COMPLAINT DEVICE HAS STILL NOT BEEN IDENTIFIED, AND OF COURSE, NO LOT NUMBER CAN BE ASSOCIATED TO THE WHATEVER DEVICE. OUR AFFILIATE, ON OUR BEHALF, HAS PRESSED THE FACILITY FOR FURTHER INFORMATION AND DETAILS; HOWEVER, THE FACILITY WOULD NOT SUPPLY ANY FURTHER INFORMATION. IN CLOSING; THE FACILITY CANNOT IDENTIFY THE COMPLAINT PRODUCT, THERE IS NO LOT NUMBER TO BE HAD, AND DESPITE REPEATED EFFORTS, NO FURTHER INFORMATION OR DETAIL IS BEING SUPPLIED. WE CANNOT TELL ANYTHING FROM THIS, WE CANNOT DISCERN THE ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT A PATIENT UNDERWENT SUCCESSFUL KNEE SURGERY SOMETIME IN 2012 WITH THE USE OF A BIOINTRAFIX SCREW AND SHEATH FOR FIXATION. AT SOME TIME SUBSEQUENTLY, THE PATIENT PRESENTED WITH SWELLING. ON (B)(6) 2013, THE PATIENT UNDERWENT A RE-SURGERY, AT THIS POINT, THE BIOINTRAFIX WAS REMOVED AND ANOTHER FIXATION DEVICE WAS USED TO RE-FIXATE. THEY NOTED THAT THE BIOINTRAFIX SCREW WAS PARTIALLY ABSORBED; ALSO, ALL LAB TEST WERE NEGATIVE. NOTHING IS BEING RETURNED, COMPLAINT DEVICES DISCARDED AT FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2013-00078.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT A PATIENT UNDERWENT SUCCESSFUL KNEE SURGERY SOMETIME IN 2012 WITH THE USE OF A BIOINTRAFIX SCREW AND SHEATH FOR FIXATION. AT SOME TIME SUBSEQUENTLY, THE PATIENT PRESENTED WITH SWELLING. ON (B)(6) 2013, THE PATIENT UNDERWENT A RE-SURGERY, AT THIS POINT, THE BIOINTRAFIX WAS REMOVED AND ANOTHER FIXATION DEVICE WAS USED TO RE-FIXATE. THEY NOTED THAT THE BIOINTRAFIX SCREW WAS PARTIALLY ABSORBED; ALSO, ALL LAB TEST WERE NEGATIVE. NOTHING IS BEING RETURNED, COMPLAINT DEVICES DISCARDED AT FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2013-00078.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT A PATIENT UNDERWENT SUCCESSFUL KNEE SURGERY SOMETIME IN 2012 WITH THE USE OF A BIOINTRAFIX SCREW AND SHEATH FOR FIXATION. APPROXIMATELY ONE YEAR SUBSEQUENT (ON (B)(6) 2013) TO THE PROCEDURE, THE PATIENT PRESENTED WITH SWELLING; LAB TEST RULED OUT INFECTION; THE SURGEON BELIEVES THAT THIS IS AN AUTO IMMUNE REACTION. THE PATIENT IS NOT BEING TREATED WITH ANY MEDICATION AND THEY BELIEVE THAT THE ISSUE WILL BE RESOLVED WHEN THE DEVICES ARE REMOVED AT SOME YET TO BE DETERMINED FUTURE RE-SURGERY. ALSO SEE ASSOCIATED MDR 1221934-2013-00078.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123647 MITEK BIOINTRAFIX SHEATH SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention