BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOSPA KNEE SYSTEM

    MDR report key: 7863456 · Received September 11, 2018

    Report

    Report Number
    3009106092-2018-00001
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    January 28, 2018
    Report Date
    February 20, 2018
    Manufacturer
    CORENTEC CO., LTD.
    Product Code
    JWH
    UDI-DI
    08806373820540
    PMA / PMN Number
    K110404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS (DHRS) FOR THE DEVICE AND CONCOMITANT PRODUCTS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. SINCE THE SIMILAR CASE WITH THE REPORTED EVENT WAS NOT FOUND DURING CUSTOMER COMPLAINTS HISTORY REVIEW, NO FURTHER ACTIONS ARE REQUIRED, BUT MONITORING THE TRENDS IS REQUIRED. ONCE ANY SUPPLEMENTAL INFORMATION IS FOUND WHICH WOULD CHANGE ANY INFORMATION OR CONCLUSIONS, ADDITIONAL INFORMATION WILL BE FILED ACCORDINGLY. WE WERE TOLD THAT THE PATIENT GOT THE REVISION KNEE CASE WITH OTHER MANUFACTURER'S DEVICE THE OTHER DAY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DISLOCATED SIX DAYS AFTER THE KNEE ARTHROPLASTY. THE FEMUR DISLOCATED FROM THE BASEPLATE WHILE THE PATIENT WAS PULLING UP THE STOCKINGS SITTING ON THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706505 LOSPA KNEE SYSTEM PROSTHESIS, KNEE JWH CORENTEC CO., LTD. 01.10.064 6BAGEY04 08806373820540

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization LOSPA PATELLAR COMPONENT 30MM (CAT NO. 01.10.961)| LOSPA TIBIAL BASEPLATE SIZE 4 (CAT NO. 01.10.504)| LOSPA TIBIAL INSERT SIZE 4 (CAT NO. 01.10.24A)