BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE +, SZ 3.5, 11 MM

    MDR report key: 19774410 · Received July 18, 2024

    Report

    Report Number
    1038671-2024-02440
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    March 11, 2024
    Report Date
    November 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159298
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: (B)(6), 02-012-48-3511 - LOGIC CR TIB INSERT SLOPE +, SZ 3.5, 11 MM, (B)(6), 02-010-03-0235 - LOGIC CR FEMORAL CEM, LEFT, SZ 3.5, (B)(6), 200-02-29 - THREE PEG PATELLA 29MM, (B)(6), 02-012-45-3525 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T, (B)(6), 201-78-81 - 3"" TROCAR, MOD. HEX 2PK. 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.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS; NEGATIVELY IMPACTED MOBILITY AND QUALITY OF LIFE, REVISION SURGERY; RESULTANT PAIN FOLLOWING SURGERY AND RECUPERATION/REHABILITATION PERIOD AND PHYSICAL THERAPY; ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN LIMITED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032903 LOGIC CR TIB INSERT SLOPE +, SZ 3.5, 11 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862159298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.