BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 3, 13MM, SLOPE +

    MDR report key: 16633161 · Received March 28, 2023

    Report

    Report Number
    1038671-2023-00533
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    August 23, 2016
    Report Date
    January 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041081
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AS STATED IN THE LEGAL DOCUMENTATION. THE LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONES. THE EXTENT OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES, PRE-REVISION RADIOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. EXACTECH TRAPEZOID TIBIAL TRAY, CATALOG NO. 204-04-34, LOT NO. 1942962; AND EXACTECH FEMORAL COMPONENT, CATALOG NO. 230-03-03, LOT NO. 2130432. Z-0019-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1 B2 G2 H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, FEMORAL LOOSENING, AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 AND RADIOGRAPHS WERE NOT PROVIDED. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. 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

    AS REPORTED BY LEGAL NOTIFICATION, THIS MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2012. THE PATIENT UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2016 SECONDARY TO POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766527 CR TIBIAL INSERT SZ 3, 13MM, SLOPE + PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 200-63-13 10885862041081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10