BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM

    MDR report key: 17379827 · Received July 24, 2023

    Report

    Report Number
    1038671-2023-01750
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    October 4, 2022
    Report Date
    January 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173713
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 3683358 02-010-01-0350 - LOGIC FEMORAL PS CEM RIGHT SZ 5. 2616550 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. 3002131 200-02-35 - THREE PEG PATELLA 35MM. 132182 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS. A20149128 620-12-02 - ACCELERATE PRP 60 ML & ACD-A. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3/G4, H6 THE FOLLOWING SECTIONS WERE CORRECTED: H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY 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. 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 55 Y/O MALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 7 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED TOTAL KNEE ARTHROPLASTY. THE PATELLA WAS EVALUATED. IT HAD SOME MILD TO MODERATE WEAR LATERALLY. UPON REMOVAL OF THE POLY, IT WAS NOTED THAT THERE WAS NOT ANY MIDSUBSTANCE WEAR AND NO BACKSIDE WEAR, BUT THERE WAS SIGNIFICANT WEAR BOTH POSTERIOR, MEDIAL AND LATERAL AT THE EDGE LOADING POSTERIORLY. NOT SURE WHETHER THIS WAS DELAMINATION OF THE POLY OR SIMPLE WEAR FROM A POSTERIOR STABILIZED KNEE WITH IMPINGEMENT POSTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947660 LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM UNK 10885862173713

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Required Intervention