BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC FEMORAL SIZE 4, LEFT

    MDR report key: 16600555 · Received March 23, 2023

    Report

    Report Number
    1038671-2023-00494
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    June 14, 2017
    Report Date
    April 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265678
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 06001016009, A10012 - GPS IMPLANT KIT V2; SERIAL #: (B)(4), CATEGORY #: 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; SERIAL #: (B)(4), CATEGORY #: 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM; SERIAL #: (B)(4), CATEGORY #: 02-012-60-2080 - LOGIC STEM EXT 20MM X 80MM; SERIAL #: (B)(4), CATEGORY #: 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; SERIAL #: (B)(4), CATEGORY #: 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; SERIAL #: (B)(4), CATEGORY #: 204-70-00 - TIBIAL STEM EXT. SCREW; SERIAL #: (B)(4), CATEGORY #: 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM; SERIAL #: (B)(4), CATEGORY #: 02-012-61-2000 - LOGIC OFFSET STEM EXT COUPLER 2MM; SERIAL #: (B)(4), CATEGORY #: 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM; SERIAL #: (B)(4), CATEGORY #: 02-012-66-2000 - METAPHYSEAL TIBIAL CONE, ML32MM; SERIAL #: (B)(4), CATEGORY #: 02-012-44-4015 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY HAVE BEEN DUE TO FEMORAL LOOSENING. 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. 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

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 62 YO MALE PATIENT EXPERIENCED ASEPTIC FEMORAL LOOSENING RESULTING IN SWELLING AND PAIN. THE PATIENT REPORTED THAT THE LEFT KNEE STARTED FEELING LOOSER. THE MRI CONFIRMED MOVEMENT. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2021. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809163 LOGIC CC FEMORAL SIZE 4, LEFT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862265678

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other| R SEE H10