BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC PSC TIB INS SZ 4 17MM

    MDR report key: 15820819 · Received November 17, 2022

    Report

    Report Number
    1038671-2022-01486
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    March 15, 2018
    Report Date
    November 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862248145
    PMA / PMN Number
    K132161
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: LOGIC CC FEMORAL SIZE 4, RIGHT (CAT# 02-010-06-0340 / SERIAL#(B)(4)). LOGIC POST. AUG. BLOCK SIZE 4, 5MM (CAT# 02-010-06-0541 / SERIAL# (B)(4)). LGC TIBIAL FIT TRAY CEM SZ 4F / 4T (CAT# 02-012-45-4040 / SERIAL# (B)(4)). LOGIC STEM EXT 14MM X 40MM (CAT# 02-012-60-1440 / SERIAL#(B)(4)). TIBIAL STEM EXT. SCREW (CAT# 204-70-00 / SERIAL# (B)(4)). CC DISTAL FEM AUGMENT SZ 4, 5MM (CAT# 208-05-04 / 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) AS REPORTED, APPROXIMATELY ONE YEAR POST INITIAL RIGHT TKA, THE 74 Y/O MALE PATIENT HAD A POLY SWAP. NO ADDITIONAL INFORMATION AVAILABLE AFTER MULTIPLE ATTEMPTS. 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, REASON NOT REPORTED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY ONE YEAR POST INITIAL RIGHT TKA, THE 74 Y/O MALE PATIENT HAD A POLY SWAP. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208998 LOGIC PSC TIB INS SZ 4 17MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LOGIC PSC TIB INS SZ 4 17MM UNK 10885862248145

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention