BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 5

    MDR report key: 18334648 · Received December 15, 2023

    Report

    Report Number
    1038671-2023-02993
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 28, 2023
    Report Date
    March 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001177
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 1490036 - 02-012-35-5015 - LOGIC TIBIA PS MOD INSERT SZ 5 15MM 4161480 - 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T 4161325 - 200-02-38 - THREE PEG PATELLA 38MM H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B4, D4 UDI NUMBER. CORRECTION: H6 CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF TIBIAL PROSTHESIS WEAR. THE ROOT CAUSE OF THE PROSTHESIS WEAR CANNOT BE CONFIRMED BY THE PROVIDED IMAGES AND CLINICAL INFORMATION, AND DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF THE INSERT 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. 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 REVISION REPORTED WAS LIKELY THE RESULT OF TIBIAL PROSTHESIS WEAR. THE ROOT CAUSE OF THE PROSTHESIS WEAR CANNOT BE CONFIRMED BY THE PROVIDED IMAGES AND CLINICAL INFORMATION, AND DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF THE INSERT 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. 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 REVISION REPORTED WAS LIKELY THE RESULT OF TIBIAL PROSTHESIS WEAR. THE ROOT CAUSE OF THE PROSTHESIS WEAR CANNOT BE CONFIRMED BY THE PROVIDED IMAGES AND CLINICAL INFORMATION, AND DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF THE INSERT 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. 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, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2015. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2023 DUE TO A LOOSE FEMUR AND RECALLED POLY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT WAS REQUIRED TO UNDERGO REVISION SURGERY DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY DUE TO WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298830 LOGIC FEMORAL PS CEM LEFT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001177

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention SEE H10.