BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 5, 9MM

    MDR report key: 16702480 · Received April 7, 2023

    Report

    Report Number
    1038671-2023-00618
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    December 11, 2017
    Report Date
    March 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054401
    PMA / PMN Number
    K954208
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED IN (B)(4) WAS LIKELY THE RESULT OF POLYETHYLENE WEAR AS STATED IN THE LEGAL DOCUMENTATION. THE EXTENT AND ROOT CAUSE OF THE POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS, PHOTOGRAPHS, OR OPERATIVE NOTES WERE NOT PROVIDED. AS A RESULT OF THE INVESTIGATION, THE CORRECT PRODUCT INFORMATION WAS IDENTIFIED. THE FOLLOWING FIELDS HAVE BEEN CORRECTED: D1, D4, G4, H4, AND H9.

    Additional Manufacturer Narrative · 0

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. CONCOMITANT MEDICAL PRODUCT(S): 02-010-06-0350 - LOGIC CC FEMORAL SIZE 5, RIGHT, 4948442; 02-010-06-0551 - LOGIC POST. AUG. BLOCK SIZE 5, 5MM, 4858435, 4858469; 02-010-06-0552 - LOGIC POST. AUG. BLOCK SIZE 5, 10MM, 4450844. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR. CONTRIBUTING FACTORS TO THE WEAR MAY HAVE BEEN ORIENTATION OF THE COMPONENTS AND/OR THE TIBIAL INSERT BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND FEMORAL 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. 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 VIA LEGAL NOTIFICATION THAT ON (B)(6) 2008, A PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT SURGERY WHERE HE WAS IMPLANTED WITH AN OPTETRAK CC POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(4)); THEN ON (B)(6) 2017, APPROXIMATELY 9 YEARS AFTER IMPLANT, UNDERWENT A RIGHT KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK CC POLYETHYLENE TIBIAL INSERT. DURING THIS REVISION PROCEDURE, THE PATIENT WAS IMPLANTED WITH A SECOND OPTETRAK LOGIC CC POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(4)). IT IS STATED THAT THE PATIENT EXPERIENCES PAIN IN HIS RIGHT KNEE AND WILL LIKELY REQUIRE A RE-REVISION SURGERY OF THE RIGHT KNEE TO REMOVE THE POLYETHYLENE LINER. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416588 CC TIBIAL INSERT SZ 5, 9MM SEE H10 JWH EXACTECH, INC. 02-012-65-5015 10885862054401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10