BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HXL VE E+ PATELLA

    MDR report key: 8677168 · Received June 6, 2019

    Report

    Report Number
    1644408-2019-00510
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    May 7, 2019
    Report Date
    July 11, 2019
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    OIY
    UDI-DI
    00888912108553
    PMA / PMN Number
    K113756
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO THE KNEE PAIN. THE PREVIOUS SURGERY AND THE REVISION DETAILED IN THIS INVESTIGATION OCCURRED OVER 1 YEAR AND 5 MONTHS APART. 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 HAS NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORDS (DHR) SHOWS THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WAS A NONCONFORMANCE ASSOCIATED WITH THE PART #130-03-735, DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS WHICH DOCUMENTS THAT OUT OF 20 QUANTITIES LOT, 1 PART WAS REJECTED AND SCRAPPED DUE TO SURFACE FINISH ON AREA "A" IS NOT SIMILAR TO PRINT. REMAINING 19 PARTS IN THE LOT MET WITH DESIGN, FIT AND FUNCTIONAL REQUIREMENTS. THE DEVICE WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF USE DURING THE PREVIOUS SURGERY. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE IN NEED OF REVIEW. THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO THE KNEE PAIN. THERE WERE NO FINDINGS DURING THIS INVESTIGATION THAT INDICATE THAT THE REPORTED DEVICE WAS THE SOURCE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S EVENT. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO THE EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL ARE SOFT TISSUE IMPINGEMENT, DEGENERATIVE BONE DISEASE, EXCESSIVE WEIGHT, PATIENT'S AGE, UNBALANCED JOINT OR TRAUMA. NO ADDITIONAL INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THAT MAY HAVE CONTRIBUTED TO THE EVENT AND HENCE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.10. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT HAVING KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466846 HXL VE E+ PATELLA DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS OIY ENCORE MEDICAL L.P. 130-03-735 156N1258 00888912108553

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 600-15-000, LOT 881500.