BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM

    MDR report key: 18643623 · Received February 5, 2024

    Report

    Report Number
    1038671-2024-00152
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    January 4, 2024
    Report Date
    July 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174529
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 3564809 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4. 3883850 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T. 3928517 200-02-35 - THREE PEG PATELLA 35MM. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. MDR SECTION CODES UPDATED/CORRECTED: E. 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

    ADDITIONAL MANUFACTURER NARRATIVE- D4 EXPIRATION DATE, D10. H3. INVESTIGATION RESULTS- THE CAUSE OF THE PATIENT'S PAIN AS RELATED TO THE RECALLED TIBIAL DEVICE CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. PATIENT IS NOT REVISED. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. PAIN IS A KNOWN CONDITION FOR JOINT REPLACEMENT PROCEDURES. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. CORRECTION- D9 DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 3564809 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4. 3883850 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T. 3928517 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.

    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: C, D. 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 FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. THE REVISION REPORTED WAS LIKELY THE RESULT OF PATELLAR AND TIBIAL INSERT PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, OR ANY COMBINATION OF THESE POSSIBILITIES. AS THE SUSPECT DEVICE WAS NOT PROVIDED, NONE OF THESE POTENTIAL CAUSES OR THEIR CONTRIBUTION TO THE SEQUENCE OF EVENTS CAN BE CONFIRMED. 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 VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT IN 2015. THIS DEVICE HAS NOT BEEN EXPLANTED. PATIENT IS REPORTING PAIN. THE PATIENT WENT TO AN ORTHOPEDIC SURGEON EARLIER THIS WEEK FOR X-RAYS, AND THE SURGEON WILL PROVIDE GUIDANCE ABOUT SURGERY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 99 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SYNOVITIS, CYST. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180504 LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862174529

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention REPORTED IN INITIAL| SEE H11