BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MJS KNEE

    MDR report key: 7264277 · Received February 12, 2018

    Report

    Report Number
    1644408-2018-00132
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    HRY
    UDI-DI
    00888912121460
    PMA / PMN Number
    K012762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO POLY WEAR. THE TIME BETWEEN THE PREVIOUS SURGERY AND THIS REVISION SURGERY IS UNKNOWN AS THE ORIGINAL SURGERY DATE WAS NOT PROVIDED OR COULD BE ESTABLISHED. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THERE ARE NO REPORTED PRE-EXISTING PATIENT HEALTH CONDITIONS. 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. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS NOT CONDUCTED SINCE THE ITEM AND OR LOT NUMBER WAS NOT PROVIDED OR DETERMINED DURING THE COMPLAINT EVALUATION. GIVEN THE LIMITED INFORMATION, EXTENSIVE SEARCH FOR AN INVOICE OF THE PREVIOUS SURGERY PRODUCED NO RESULTS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED FOR FURTHER EVALUATION. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO POLY WEAR. THIS COMPLAINT WILL BE CLOSED WITH THE ITEM AND OR LOT NUMBER UNKNOWN PENDING RECEIPT OF ADDITIONAL INFORMATION. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE POLY WEARING AND NEEDING TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107930 MJS KNEE INSERT,TIBIAL#3 MJS ANATOMIC 1 STD. 10X70 HRY ENCORE MEDICAL L.P. 00888912121460

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 77-0001-5B