BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 13MM

    MDR report key: 19821105 · Received July 24, 2024

    Report

    Report Number
    1038671-2024-02507
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    May 15, 2024
    Report Date
    November 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001825
    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: (3778842) 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3. (4830773) 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T. ( 4891955) 200-02-32 - THREE PEG PATELLA 32MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z0021-2022; 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6: TYPE OF INVESTIGATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6: HEALTH IMPACT - CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE, THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WHERE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES, INCLUDING BUT NOT LIMITED TO SEVERE PAIN, SCARRING, SWELLING, EFFUSION, ANTALGIC GAIT, INFLAMMATION, KNEE POPPING AND CRACKING, INSTABILITY, AND OTHER INJURIES WHICH HAVE RESULTED IN PAST AND FUTURE MEDICAL EXPENSES, SURGERY, PAST AND FUTURE LOST EARNINGS AND EARNING CAPACITY, ANXIETY, EMOTIONAL DISTRESS AND GENERAL DAMAGES.. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343532 LOGIC TIBIA PS MOD INSRT SZ 3 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R