BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 4

    MDR report key: 15245537 · Received August 17, 2022

    Report

    Report Number
    1038671-2022-00930
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    October 26, 2020
    Report Date
    October 11, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001252
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    AS A RESULT OF ADDITIONAL INFORMATION PROVIDED, THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5, B7, D1, D4, D8, D10, E4, G4, AND H4. FURTHER INFORMATION AND/OR RE-OPENED INVESTIGATION RESULTS WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT. D10. CONCOMITANTS: OPTETRAK LOGIC FIT TIBIAL TRAY (02-012-41-4040, 3003653). OPTETRAK LOGIC TIBIAL INSERT (02-012-35-4011, 2450163) . OPTETRAK 3 PEG PATELLA (200-02-35, 2956577).

    Additional Manufacturer Narrative · 0

    H3. UPDATED INVESTIGATION RESULTS-THE REVISION CAPTURED WAS LIKELY DUE TO PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. THE ACHILLES TENDON INJURY MAY HAVE RESULTED IN A CHANGE IN THE PATIENTS GAIT DUE TO PAIN OR MEDICAL INTERVENTION, WHICH COULD LEAD TO ABNORMAL STRESS ON THE DEVICES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; NO REASON FOR REVISION WAS GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT SUSTAINED INJURIES RESULTING FROM A KNEE PROSTHESIS IMPLANTED A THE TIME OF HIS RIGHT PROCEDURE PERFORMED ON OR ABOUT (B)(6) 2014, AND REVISED ON OR ABOUT (B)(6) 2020.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2014. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 6 YEARS 6 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT POST-OP DIAGNOSIS: ASEPTIC LOOSENING STATUS POST RIGHT TOTAL KNEE ARTHROPLASTY. THE SURGEON NOTED THERE WAS MARKED SYNOVITIS WAS ENCOUNTERED WITH TISSUE CHANGES SUGGESTIVE OF OSTEOLYSIS. THE POLYETHYLENE COMPONENT DEMONSTRATED PITTED WEAR AND SOME EVIDENCE OF OXIDATION WITH YELLOWISH DISCOLORATION GROSSLY VISIBLE. THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE, AND WAS NOTED TO BE DEBONDED FROM CEMENT IN SEVERAL AREAS INCLUDING THE ANTERIOR FLANGE AND THE LATERAL DISTAL CONDYLE. THERE WAS EVIDENCE OF DAMAGE TO THE BONY ARCHITECTURE NOTED SECONDARY TO OSTEOLYSIS. LARGE AMOUNTS OF OSTEOLYTIC TISSUE AND MEMBRANE WERE REMOVED PRIMARILY FROM THE MEDIAL CONDYLE REVEALING A CONTAINED TYPE IIB DEFECT ON THE FEMUR. THE PATELLAR BUTTON WAS NOTED TO BE WELL FIXED. 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
    2379641 LOGIC FEMORAL PS CEM RIGHT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001252

    Patients

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