BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 2

    MDR report key: 21549878 · Received March 7, 2025

    Report

    Report Number
    1038671-2025-01481
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    September 13, 2021
    Report Date
    March 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001122
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF PROSTHESIS WEAR AND FEMORAL LOOSENING. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE TIBIAL LOOSENING AND INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED TIBIAL LOOSENING COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. THE PROSTHESIS WEAR WAS LIKELY DUE TO EXCESSIVE LOADING OF THE FEMORAL COMPONENT ON THE ANTERIOR PORTION OF THE TIBIAL INSERT AND THIRD BODY WEAR. THE LOOSENING AND OSTEOLYSIS WERE LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONES AND PATIENT-RELATED CONDITIONS. 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

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. D10 CONCOMITANT PRODUCTS: 2095417 - 02-012-44-2015 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 15MM; 2956799 - 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; 3945262 - 200-02-29 - THREE PEG PATELLA 29MM; 3942455 - 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE; 2919683 - 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 YRS POPSTOP THE INITIAL L TKA, THIS FEMALE PATIENT¿S LEFT KNEE WAS REVISED DUE TO POLY WEAR AND OSTEOLYSIS. THE INSERT WAS REMOVED, THE FEMUR AND TIBIA BOTH CHECKED AND FOUND TO BE LOOSE. PATIENT HAD SIGNIFICANT BONE LOSS AND NEEDED A DISTAL FEMORAL REPLACEMENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE HOSPITAL DISCARDED THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232043 LOGIC FEMORAL PS CEM LEFT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2 10885862001122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H