BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOSPA KNEE SYSTEM OR EXULT KNEE SYSTEM

    MDR report key: 17946723 · Received October 16, 2023

    Report

    Report Number
    3009106092-2023-00001
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    April 11, 2019
    Report Date
    October 25, 2019
    Manufacturer
    CORENTEC CO.,LTD.
    Product Code
    JWH
    PMA / PMN Number
    K110404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO "INTERNAL AUDIT PROCEDURE (CSRP-08-01)" WHICH IS INTERNAL PROCEDURE, CORENTEC SHALL RETRIEVE THE PRODUCT FROM THE HOSPITAL, SURGEON, PATIENT, OR ANY OTHER LOCATION WHERE ISSUED, SO THAT PROPER INVESTIGATION CAN BE CONDUCTED. HOWEVER, MANDATORY INFORMATION(SUCH AS PATIENT, SURGEON, HOSPITAL, PRODUCTION BATCH, ETC.) TO CONDUCT IT HAS BEEN UNIDENTIFIED IN THE REPORT (#MW5145170), SO CORENTEC CANNOT ATTEMPT THE PRODUCT RETRIEVAL AND THE INVESTIGATION IS BEING LIMITED. ALSO, CORENTEC CANNOT FIND OUT ANY OTHER SURVEILLANCE RECORD THAT CAN BE RELATED WITH SUBJECTED MDR (#MW5145170) IN THE QMS. THIS REPORTING IS UNIQUE IN THE HISTORY. IN ADDITION, CORENTEC COULD NOT FIND OUT ANY OTHER CHANGE RECORD FOR THE MATERIAL, AND ANY RECORD FOR NDR THAT COULD OCCUR THIS TYPE OF FAILURE SINCE THE PRODUCT WAS INITIALLY CLEARED 510(K). UNFORTUNATELY, ROOT CAUSE INVESTIGATION CAN NOT HAVE ANY PROGRESS UNDER THIS RESTRICTED STATUS, SO CORENTEC REMAINS WATCHING MARKET AND KEEPING SURVEILLANCE ALSO CORENTEC WILL TRY TO FIND OUT MANDATORY INFORMATION FOR SUBJECTED MDR IN THE MARKET. ONCE ANY FURTHER INFORMATION THAT COULD RESUME THE ROOT CAUSE ANALYSIS IS FOUND OR REPORTED, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    LOSPA PROTHESIS. IT FELL APART IN 2 YEARS AND REQUIRED REVISION SURGERY WITH A COMMONLY USED ZIMMER PROSTHESIS. 2021 XRAY SHOWED THAT THE KNEE CAP AND THE PROTHESIS WERE BOTH FRACTURED COMPLETELY IN HALF (B)(6) 2021 SURGERY TO INCORPORATE A KNEE IMPLANT (ZIMMER) (B)(6) 2021 SURGERY TO REPAIR STRETCHED LIGAMENTS ON BOTH SIDES OF KNEE THAT CAUSED EXCESSIVE MOBILITY, LOOSENING OF THE KNEE. SURGEON IMPLANTED LARGER SPACER TO STRETCH THE LIGAMENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283527 LOSPA KNEE SYSTEM OR EXULT KNEE SYSTEM LOSPA FEMORAL COMPONENT, PATELLAR COMPONENT JWH CORENTEC CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Unknown Hospitalization