BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2 9MM

    MDR report key: 19983033 · Received August 14, 2024

    Report

    Report Number
    1038671-2024-02836
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    January 5, 2023
    Report Date
    August 14, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001726
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: (11024) 203-90-21 - (11-2716) HALL PWR PRO VRSPWR+ 90X13/21X1.19MM. (1825517) 02-010-01-0220 - LOGIC FEMORAL PS CEM LEFT SZ 2. (1968258) 02-012-35-2011 - LOGIC TIBIA PS MOD INSRT SZ 2 11MM. (1974567) 200-02-29 - THREE PEG PATELLA 29MM. (1978406) 02-012-41-2010 - LOGIC TIBIA TRAPTRAY CEM SZ 2F/1T. (1984231) 02-012-41-2010 - LOGIC TIBIA TRAPTRAY CEM SZ 2F/1T. (2006105) 200-02-32 - THREE PEG PATELLA 32MM. (2017522) 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM. (2017555) 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM. (2024335) 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE. (2024336) 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE. (2035766) 204-70-00 - TIBIAL STEM EXT. SCREW. (2035792) 204-70-00 - TIBIAL STEM EXT. SCREW. (92027) 203-90-21 - (11-2716) HALL PWR PRO VRSPWR+ 90X13/21X1.19MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 141 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580247 LOGIC TIBIA PS MOD INSRT SZ 2 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11.