BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR FEMORAL CEM, RIGHT, SZ 3

    MDR report key: 21233785 · Received January 24, 2025

    Report

    Report Number
    1038671-2025-00412
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    May 8, 2017
    Report Date
    January 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862158116
    PMA / PMN Number
    K111400
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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, H4. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, FRACTURE, FEMORAL LOOSENING, AND TIBIAL 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. 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

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. D10 CONCOMITANTS: (B)(6), 02-012-49-3009 - LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM. (B)(6), 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. (B)(6), 1510-S - CEMEX SYSTEM FAST 70 GM. (B)(6), 200-02-32 - THREE PEG PATELLA 32MM. (B)(6), 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS. (B)(6), 620-11-02 - ACCELERATE CONC. SYS REP BY 620-12-02. (B)(6) - STERILE DISPOSABLE CONTAINERS.

    Description of Event or Problem · 0

    LEGAL CASE - USA. PATIENT ID: (B)(6). (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. HE HAD RIGHT KNEE REVISION ON (B)(6) 2017, APPROXIMATELY 4 YEARS 9 MONTHS AFTER THEIR INITIAL REPLACEMENT SURGERY. POSTOPERATIVE DIAGNOSIS: FRACTURED POLYETHYLENE FAILURE WITH POLYETHYLENE DEBRIS RESULTING IN SEVERE SYNOVITIS. LOOSE FEMORAL COMPONENT WAS PRESENT. POST OP VISIT OF (B)(6) 2017- PATIENT HAS RESUMED ALL ACTIVITIES WITHOUT RESTRICTION. NO INSTABILITY OR PAIN, HAS VERY GOOD RANGE OF MOTION AND NO OTHER SYMPTOMS. 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. (B)(6) 02-012-49-3009 - LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM. ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K111400. RECALL: Z-0021-2022. CONCOMITANTS: (B)(6) 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3. (B)(6) 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. (B)(6) 1510-S - CEMEX SYSTEM FAST 70 GM. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. (B)(6) 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS. (B)(6) 620-11-02 - ACCELERATE CONC. SYS REP BY 620-12-02. (B)(6) - STERILE DISPOSABLE CONTAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017141 LOGIC CR FEMORAL CEM, RIGHT, SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. LOGIC CR FEMORAL CEM, RIGHT, S 10885862158116

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female