BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIAL KNEE COMPONENTS

    MDR report key: 20678125 · Received November 13, 2024

    Report

    Report Number
    1038671-2024-04383
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    December 29, 2021
    Report Date
    November 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 4136622 - 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4. 4165214 - 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4. 3663372 - 02-012-35-4009 - LOGIC TIBIA PS MOD INSRT SZ 4 9MM. 2928146 - 02-012-41-1010 - LOGIC TIBIA TRAPTRAY CEM SZ 1F/1T. 4040341 - 02-012-41-4030 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/3T. 4195256 - 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T. 3648290 - 02-012-44-2013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 13MM. 4045950 - 02-012-44-4009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM. 4188754 - 142-28-00 - COCR FEM HEAD 28MM +0 OFFSET 12/14. 4160946 - 160-31-15 - PF SPLINE PLASMA W/HA EXT OFFSET SZ 15. 4168429 - 200-02-32 - THREE PEG PATELLA 32MM. 4200097 - 200-02-35 - THREE PEG PATELLA 35MM. 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. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SWELLING/ EDEMA, PAIN AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996096 LOGIC TIBIAL KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R SEE H10