BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU CC FEMORAL SIZE 3 RIGHT

    MDR report key: 15393569 · Received September 9, 2022

    Report

    Report Number
    1038671-2022-01082
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    December 29, 2016
    Report Date
    February 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265715
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: - LOGIC CC FEMORAL SIZE 3, RIGHT (CAT# 02-010-06-0330 / SERIAL# (B)(4). - LOGI LOGIC TIBIA PS MOD INSRT SZ 3 13MM (CAT# 02-012-35-3013 / SERIAL# (B)(4). - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T (CAT# 02-012-45-3030 / SERIAL# (B)(4). - C STEM EXT 14MM X 80MM (CAT# 02-012-60-1480 / SERIAL# (B)(4) . - LOGIC FIT/RBK AUGMENT 1/2 BLOCK SZ 3, 5MM (CAT# 02-012-50-3011 / SERIAL# (B)(4). - LOGIC POST. AUG. BLOCK SIZE 3, 5MM (CAT# 02-010-06-0531 / SERIAL# (B)(4) . - LOGIC FIT/RBK AUGMENT 1/2 BLOCK SZ 3, 5MM (CAT# 02-012-50-3011 / SERIAL# (B)(4). - CC DISTAL FEM AUGMENT SZ 3, 5MM (CAT# 208-05-03 / SERIAL# (B)(4). - METAPHYSEAL TIBIAL CONE, ML32MM (CAT# 02-012-66-2000 / SERIAL# (B)(4). - TIBIAL STEM EXT. SCREW (CAT# 204-70-00 / SERIAL# (B)(4). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF BOTH PATIENT-RELATED CONDITIONS AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENTS AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES/PRE-REVISION RADIOGRAPHS WERE NOT PROVIDED. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF ¿LOOSENING - FEMORAL¿ IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE FEMORAL COMPONENT AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B2, D1, D4, D8, G1, H4, H6: CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS. P CLASS- THE REVISION REPORTED WAS LIKELY THE RESULT OF BOTH PATIENT-RELATED CONDITIONS AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENTS AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES/PRE-REVISION 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, APPROXIMATELY SIX MONTHS POST RIGHT TKA, PATIENT HAD A REVISION OF THE LOGIC CC FEMORAL CONSTRUCT DUE TO LOOSENING OF THE FEMORAL COMPONENTS. IT WAS REVISED USING LOGIC CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277685 TRU CC FEMORAL SIZE 3 RIGHT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC STEM EXT 14MM X 40MM UNK 10885862265715

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R