BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY ELBOW

    MDR report key: 6139732 · Received December 1, 2016

    Report

    Report Number
    1644408-2016-00930
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 1, 2016
    Report Date
    January 11, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDC
    UDI-DI
    00888912225083
    PMA / PMN Number
    K013042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS 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 POSSIBLE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. INITIAL OR PROLONGED HOSPITALIZATION WAS REQUIRED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. THE LOT NUMBERS OF THE DEVICES INVOLVED IN THIS EVENT WERE NOT PROVIDED. TO ADEQUATELY INVESTIGATE THIS EVENT, 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, AS OF 8 DEC. 2016 ZIMMER-BIOMET PERFORMED A SEARCH OF INVOICES AND CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS INCIDENT. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO AN INFECTION. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. WITH THE LIMITED INFORMATION PROVIDED ABOUT THE PATIENT AND THE DEVICES REMOVED DURING THE REVISION SURGERY, IT IS IMPOSSIBLE TO DETERMINE THE SOURCE OF THE INFECTION. CONTAINMENT BASED ON THE INFORMATION SUBMITTED WITH THIS COMPLAINT, IT IS NOT POSSIBLE AS THE AGENT WAS UNABLE TO SUPPLY THE LOT NUMBERS. THE ONLY PART NUMBERS PROVIDED IS THAT OF THE DEVICES IMPLANTED DURING THE REVISION SURGERY.

    Description of Event or Problem · 1

    REVISION SURGERY: DUE TO THE PATIENT ACQUIRING A POST OP INFECTION. THE IMPLANTS WERE REMOVED BEFORE WE ACQUIRED THE SYSTEM. THIS WAS A RE-IMPLANT OF THE LISTED PART NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788220 DISCOVERY ELBOW DISC ULNA BEARING KIT JDC ENCORE MEDICAL, L.P. 00888912225083

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 114700| 114905