BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOSPA TOTAL KNEE REPLACMENT SYSTEM

    MDR report key: 5693646 · Received June 1, 2016

    Report

    Report Number
    3009106092-2016-00001
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    September 9, 2014
    Report Date
    April 1, 2016
    Manufacturer
    CORENTEC CO., LTD.
    Product Code
    JWH
    UDI-DI
    08806373820182
    PMA / PMN Number
    K110404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS IN REFERENCE TO THE EVENT DESCRIBED BY MW5061452. PATIENT CONTACTED CORENTEC VIA PHONE CALL TO REPORT AN EVENT ON (B)(6) 2015. PATIENT INDICATED THAT SHE HAD UNDERGONE A TOTAL KNEE ARTHROPLASTY PROCEDURE IN THE (B)(6) 2012 TIMEFRAME. THE CALLER STATED THAT HER "KNEE WAS CROOKED AND PAINFUL", AND INDICATED THAT IT WAS LATER REVISED BY AN ALTERNATE SURGEON IN THE (B)(6) 2014. PATIENT SUBSEQUENTLY FORWARDED TWO DOCUMENTS TO CORENTEC THAT PROVIDED SURGEON INFORMATION AND THE INTRAOPERATIVE DEVICE USE REPORT. THE INDICATED CATALOG NUMBER ON THE DEVICE USE REPORT WAS FOR A LOSPA FEMORAL - LEFT IMPLANT WHERE THE INTRAOPERATIVE REPORT INDICATED "BODY SITE: KNEE RIGHT', THEREBY RAISING THE POSSIBILITY OF A DISCREPANCY IN COMPONENT LATERALITY. CORENTEC IDENTIFIED THIS DISCREPANCY AND INITIATED A PRODUCT REVIEW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ORDER TO CONFIRM COINCIDENCE OF LOSPA FEMORAL LABELING, CATALOG NUMBER, AND QUALITY ASSURANCE RECORDS. THE IMPLANTED PART AND LABEL WAS CONFIRMED TO BE LEFT, AND IT WAS DETERMINED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ADDITIONALLY, CORENTEC REQUESTED POST-OPERATIVE RADIOGRAPHS FROM THE PATIENT CONFIRMING THAT THE PRIMARY TKA SURGERY WAS PERFORMED ON THE PATIENT'S LEFT KNEE. ADDITIONALLY, A REVIEW OF THE DHR RECORDS OF THE OTHER TKA COMPONENTS IMPLANTED WAS PERFORMED (TIBIAL BASEPLATE, TIBIAL INSERT, PATELLAR COMPONENT), AND DETERMINED THAT ALL WERE MANUFACTURED TO SPECIFICATION. A REVIEW OF CORENTEC'S CUSTOMER COMPLAINT HISTORIES WAS UNDERTAKEN AND DID NOT IDENTIFY ANY SIMILAR EVENTS, OR ANY OTHER EVENT FOR THE REPORTED LOT. RESULTS OF THIS INVESTIGATION WERE SHARED WITH THE PATIENT, AND NO FURTHER RESPONSE WAS RECEIVED, TILL DATE. HENCE THE CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. FURTHER INFORMATION IS REQUIRED SUCH AS PRODUCT RETURN, PRIMARY AND REVISIONARY OPERATION REPORT ALONG WITH PRE/POST-OP X-RAYS, AND FOLLOW-UP NOTES FOR PATIENT. NO FURTHER INVESTIGATION CAN BE UNDERTAKEN AT THIS TIME. THIS REPORT WILL BE REOPENED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE. ADDITIONAL INFORMATION: MW5061452 STATED SIX (6) DEVICE INFORMATION, HOWEVER DEVICE-6 - BONE CEMENT IS NOT A PRODUCT MANUFACTURED OR DISTRIBUTED BY CORENTEC. DEVICE-1 COMPONENT PATELLAR (PART NO. 01.10.961) WAS IMPLANTED. DEVICE-2 COMPONENT PATELLAR (PART NO. 01.10.981) WAS NOT IMPLANTED AS CONFIRMED BY THE HOSPITAL'S REPORTING SHEET. THEREFORE, THIS REPORT DOES NOT INCLUDE DEVICE-2.

    Description of Event or Problem · 1

    THE PATIENT HAD A TOTAL KNEE REPLACEMENT IN (B)(6) 2012. AND THEN, THE PATIENT STATED THAT HER KNEE WAS CROOKED, SWOLLEN AND PAINFUL. ON (B)(6) 2014, SHE HAD REVISION WITH OTHER COMPANY'S PRODUCTS, AND WAS STILL IN SEVERE PAIN AND TROUBLE IN WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347502 LOSPA TOTAL KNEE REPLACMENT SYSTEM TOTAL KNEE REPLACEMENT SYSTEM COMPONENTS JWH CORENTEC CO., LTD. 01.10.007 111011011 08806373820182

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other