BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 5 15MM

    MDR report key: 17355901 · Received July 19, 2023

    Report

    Report Number
    1038671-2023-01706
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    December 5, 2022
    Report Date
    March 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001955
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 2996509 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5; 2741467 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5; 2951048 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T; 3585943 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T; 3563142 200-02-41 - THREE PEG PATELLA 41MM; 3606553 200-02-41 - THREE PEG PATELLA 41MM; 1765968 02-012-35-5015 - LOGIC TIBIA PS MOD INSRT SZ 5 15MM.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. 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, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 8 YEARS 5 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED BILATERAL TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING AND POLYETHYLENE WEAR. THE RIGHT PATELLA WAS FOUND TO BE WELL FIXED. THE FEMORAL COMPONENT WAS EASILY DISIMPACTED FROM THE INTACT CEMENT MANTLE. TIBIA WAS CHECKED AND WAS FOUND TO BE WELL FIXED. THERE WAS A LARGE CYST POSTERIOR LATERAL, WHICH WAS NOT DECOMPRESSED FROM THE ARTHROTOMY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38804 LOGIC TIBIA PS MOD INSRT SZ 5 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-35-5013 UNK 10885862001955

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention SEE H10.