BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY ELBOW

    MDR report key: 6187644 · Received December 19, 2016

    Report

    Report Number
    1644408-2016-01049
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 10, 2016
    Report Date
    March 6, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDC
    UDI-DI
    00888912224833
    PMA / PMN Number
    K051975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS A STAGED REVISION DUE TO AN INFECTION. STAGE 1 WAS PERFORMED (B)(6) 2016 AND WAS THE REMOVAL OF A POLY AND CONDYLE AND INSERTION OF ANTIBIOTIC BEADS. STAGE 2 OF SURGERY ON (B)(6) 2016 WAS THE REMOVAL OF THE ANTIBIOTIC BEADS AND REIMPLANTATION OF POLY AND CONDYLES. THE ORIGINAL SURGERY TOOK PLACE 6 TO 7 YEARS PRIOR; THE EXACT DATE OF THE ORIGINAL SURGERY IS UNKNOWN. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO (B)(4) FOR EXAMINATION. THE LOT NUMBERS OF THE DEVICES INVOLVED IN THIS EVENT WERE NOT PROVIDED. TO ADEQUATELY INVESTIGATE THIS EVENT, THE LOT NUMBERS ARE NECESSARY. IN ADDITION TO THE LOT NUMBERS NOT BEING SUPPLIED, INFORMATION REGARDING CULTURES IDENTIFIED IN THE INFECTION AND THE SEVERITY OF THE INFECTION WAS NOT SUPPLIED. IF THIS INFORMATION IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. ATTEMPTS WERE MADE TO OBTAIN THE LOT NUMBERS OF THE DEVICES THAT WERE REMOVED; HOWEVER, THIS INFORMATION WAS NOT AVAILABLE. WITHOUT THIS INFORMATION, THIS INVESTIGATION IS LIMITED IN SCOPE. THE REASON OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO AN INFECTION. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE OF THE CONTROL OF (B)(4). WITH THE LIMITED INFORMATION PROVIDED ABOUT THE PATIENT AND THE DEVICES REMOVED DURING THE REVISION SURGERY, IT IS IMPOSSIBLE TO DETERMINE THE SOURCE/ROOT CAUSE OF THE INFECTION.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO AN INFECTION; WITH A STAGED REVISION. STAGE 1 WAS PERFORMED ON (B)(6) 2016 AND WAS THE REMOVAL OF THE POLY AND CONDYLE AND THE INSERTION OF ANTIBIOTIC BEADS. THE ORIGINAL SURGERY TOOK PLACE 6 TO 7 YEARS PRIOR. STAGE 2 OF THE SURGERY WAS ON (B)(6) 2016 AND WAS THE REMOVAL OF THE ANTIBIOTIC BEADS AND REIMPLANTATION OF POLY AND CONDYLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835937 DISCOVERY ELBOW DISC CONDYLE KIT W/ HEXALOBULA JDC ENCORE MEDICAL, L.P. 00888912224833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 114833