BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 4 9MM

    MDR report key: 15713762 · Received November 2, 2022

    Report

    Report Number
    1038671-2022-01394
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    June 20, 2018
    Report Date
    April 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001887
    PMA / PMN Number
    K033883
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION: CONCOMITANT DEVICE(S): 2990037 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4, 35156 203-96-42 - 11-4132 STRYKER SYS 6 90 X 13/ 21 X 1.19, 3570730 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T, 3573052 200-02-32 - THREE PEG PATELLA 32 MM, AA7196 1500-S - CEMEX SYSTEM 80G, AND AA7229 ASA0030 - STERILE DISPOSABLE CONTAINERS.

    Additional Manufacturer Narrative · 0

    ADDED CONTENT TO D8 AND E4. H6: INVESTIGATION RESULTS - THE REASON FOR THE REVISION MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR AND LOOSENING AS REPORTED. HOWEVER, THE REPORTED PROSTHESIS WEAR AND POTENTIAL CONTRIBUTIONS OF IMPLANT POSITIONING AND/OR PATIENT-RELATED CONDITIONS TO THE SEQUENCE OF EVENTS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND LIMITED INFORMATION WAS PROVIDED AT THE TIME OF EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, D8, H6 - HEALTH EFFECT - CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION AND H11. THE REASON FOR THE REVISION MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR AND LOOSENING AS REPORTED. HOWEVER, THE REPORTED PROSTHESIS WEAR AND POTENTIAL CONTRIBUTIONS OF IMPLANT POSITIONING AND/OR PATIENT-RELATED CONDITIONS TO THE SEQUENCE OF EVENTS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND LIMITED INFORMATION WAS PROVIDED AT THE TIME OF EVALUATION. 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 4 YEARS POST OP THE INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. PATIENT HAD LOOSE COMPONENTS AND OSTEOLYSIS. FOLLOWING THE REVISION SURGERY, PLAINTIFF CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING. NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THIS IS REPORT 1 OF 3 FOR THIS EVENT/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400228 LOGIC TIBIA PS MOD INSRT SZ 4 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-35-4009 UNK 10885862001887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R