BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORENTEC LOSPA SIZE 6-KNEE PROSTHESIS

    MDR report key: 17690094 · Received September 5, 2023

    Report

    Report Number
    MW5145170
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    July 3, 2017
    Report Date
    August 29, 2023
    Manufacturer
    CORENTEC CO., LTD.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD KNEE REPLACEMENT SURGERY AND SUBPAR PROSTHESIS WAS USED. THE PRODUCT NAME WAS CORENTEC LOSPA PROTHESIS. IT FELL APART IN 2 YEARS AND REQUIRED REVISION SURGERY WITH A COMMONLY USED ZIMMER PROSTHESIS. (B)(6) 2021 REVISION SURGERY NOTES AS THEY ARE WRITTEN IN OPERATIVE REPORT: "POST WAS ALMOST JUMPING IN APPROXIMATELY 50 DEGREES OF FLEXION WITH A VARUS THRUST. THE PATELLA BUTTON FELL OUT ONTO THE FLOOR. THE CEMENT HAD NO FIXATION TO THE FEMUR WHATSOEVER. CEMENT DID REMAIN ON THE BONE. PREVIOUS TIBIA WAS IN A SIGNIFICANT AMOUNT OF VARUS. THE PATELLA MEASURED APPROXIMATELY 5 MM. DID NOT RESECT THE PATELLA AS IT WAS ALREADY QUITE THIN AT ITS LOWEST POINT OF ABOUT 4-5 MM AND AT THE UPPER THICKEST POINT OF ABOUT 10-12 MM." (B)(6) 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 (B)(6) 2022 REPEATED OFFICE VISITS TO REPORT KNEE PAIN AND IN ADDITION BEGAN TO EXPERIENCE EXCRUCIATING NERVE PAIN FROM MY BUTTOCKS (SCIATIC NERVE) DOWN TO MY ANKLE AND A DECREASE IN MOBILITY. SURGEON SAID "THERE IS STRUCTURALLY NOTHING WRONG. YOUR KNEE IS NOT CAUSING THE PAIN." (B)(6) 2022 KNEE PROCEDURE-NERVE DESTRUCTION BY NEUROLYTIC AGENT (B)(6) 2023 KNEE PROCEDURE-NERVE DESTRUCTION BY NEUROLYTIC AGENT (B)(6) 2023 LUMBAR PROCEDURE-EPIDURAL STEROID INJECTION (HAD NEGATIVE REACTION AND TEMPORARY PARALYSIS) (B)(6) 2023 XRAYS WERE TAKEN AND I WAS INFORMED THAT THE PROSTHETIC KNEE IMPLANT WAS DETACHED AND WAS ROLLING IN ALL DIRECTIONS IN THE KNEE CAVITY. A REPLACEMENT KNEE IMPLANT OR IMPLANT REMOVAL WILL BE NECESSARY TO STOP THE PAIN AND INCREASE MY MOBILITY. I HAVE CHRONIC KIDNEY DISEASE FROM TAKING IBUPROFEN FOR PAIN. REFERENCE REPORTS: MW5145171, MW5145172.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090625 CORENTEC LOSPA SIZE 6-KNEE PROSTHESIS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH CORENTEC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| S| H "EPIDURAL STEROID INJECTION"| "NEUROLYTIC AGENT"| BONE CEMENT| IBUPROFEN