BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 9MM

    MDR report key: 17661946 · Received August 31, 2023

    Report

    Report Number
    1038671-2023-02115
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    December 11, 2015
    Report Date
    January 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174543
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 3971479 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5. 4078551 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM. 4116864 200-02-41 - THREE PEG PATELLA 41MM. 4132147 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. 4152125 204-70-00 - TIBIAL STEM EXT. SCREW. AA7754 1400-AG - CEMEX GENTO LOW VISCOSITY 40G KIT. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. DEVICE HAS NOT BEEN EXPLANTED. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN AND DISCOMFORT. THE PATIENT HAS SUFFERED DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124877 LOGIC CR TIB INSERT STD, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. UNK 10885862174543

    Patients

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