BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM

    MDR report key: 21129921 · Received January 10, 2025

    Report

    Report Number
    1038671-2025-00199
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 2, 2022
    Report Date
    January 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862144331
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2022-01601 THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL K111400; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2022-01601. THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF TIBIAL LOOSENING. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SCAR TISSUE, FAILURE OF IMPLANT, SWELLING/EDEMA, DISCOMFORT, OSTEOLYSIS AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. RIGHT KNEE FEMUR, TIBIA AND POLY COMPONENTS WERE REMOVED AND REVISED TO A COMPETITOR¿S DEVICES. POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE FAILURE. REVISION OF FEMORAL AND TIBIAL COMPONENTS TO A COMPETITOR¿S DEVICES. THE PATIENT PRESENTED WITH PAIN AND SWELLING. X-RAY DEMONSTRATED THAT THE POLYETHYLENE HEIGHT IN HER KNEE HAD DECREASED BY ALMOST 50%, EXTENSIVE BONE REABSORPTION AND OSTEOLYSIS WITH THE ANTERIOR TIBIA BELOW THE TIBIAL BASEPLATE. MRI SHOWED ADVANCED PROGRESSIVE RADIOLUCENCY AROUND THE TIBIAL COMPONENT SUGGESTIVE OF ASEPTIC LOOSENING AND SIGNIFICANT OSTEOLYSIS WITHIN THE MEDIAL FEMORAL CONDYLE. THERE WERE SEVERAL FLAKES OF POLYETHYLENE IN THE KNEE. THE PATELLAR COMPONENT WAS IN GOOD CONDITION WITH NO LOOSENING. NEW DEVICES WERE TRIALED AND IMPLANTED. A COMPRESSIVE KNEE DRESSING AND KNEE IMMOBILIZER WERE APPLIED. THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE SAVED FOR PATIENT. NO EXACTECH INSTRUMENTS WERE USED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498064 LOGIC CR TIB INSERT STD, SZ 1.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862144331

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R