BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC PS INSERT SZ 1.5, 9MM

    MDR report key: 16527321 · Received March 13, 2023

    Report

    Report Number
    1038671-2023-00410
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    December 25, 2022
    Report Date
    June 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862180759
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES; NO DEVICE INFORMATION WAS PROVIDED. THE CAUSE OF THE PATIENT¿S INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED VIA CLINICAL STUDY THAT THE 78 YO FEMALE PATIENT HAD AN INFECTION. ON (B)(6) 2022, SHE WENT TO THE ICUS DUE TO PAIN IN HER RIGHT KNEE, FUNCTIONAL LIMITATION AND THAT ON EXAMINATION REDNESS AND SUPPURATION OF MATERIAL FROM THE PROXIMAL PART OF THE HERDIA (WOUND) WAS EVIDENCED, A CURE WAS PERFORMED, AND SAMPLES WERE TAKEN FOR CULTURE. ON (B)(6) 2022, SURGICAL DEBRIDEMENT AND NEW SAMPLING FOR CULTURE WAS CARRIED OUT. DEBRIDEMENT IS REPEATED ON (B)(6) 2022, PERFORMING DAIR ((DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION) WITH CHANGE OF MOVING PARTS. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICE AND UNLIKELY RELATED TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-010-01-0315 - LOGIC FEMORAL PS CEM RIGHT SZ 1.5; 02-012-45-1515 - LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REPORTED SURGICAL INTERVENTION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR SURGICAL PROCEDURE. ADDITIONALLY, INFECTION IS A KNOWN SURGICAL RISK, AS OUTLINED IN THE IFU. D1: CORRECTED. H4: UNKNOWN. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 78 YO FEMALE PATIENT HAD AN INFECTION. ON (B)(6) 2022, SHE WENT TO THE ICUS DUE TO PAIN IN HER RIGHT KNEE, FUNCTIONAL LIMITATION AND THAT ON EXAMINATION REDNESS AND SUPPURATION OF MATERIAL FROM THE PROXIMAL PART OF THE HERDIA (WOUND) WAS EVIDENCED, A CURE WAS PERFORMED, AND SAMPLES WERE TAKEN FOR CULTURE. ON (B)(6) 2022, SURGICAL DEBRIDEMENT AND NEW SAMPLING FOR CULTURE WAS CARRIED OUT. DEBRIDEMENT IS REPEATED ON (B)(6) 2022, PERFORMING DAIR ((DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION) WITH CHANGE OF MOVING PARTS. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICE AND UNLIKELY RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 78 YO FEMALE PATIENT HAD AN INFECTION. ON (B)(6) 2022, SHE WENT TO THE ICUS DUE TO PAIN IN HER RIGHT KNEE, FUNCTIONAL LIMITATION AND THAT ON EXAMINATION REDNESS AND SUPPURATION OF MATERIAL FROM THE PROXIMAL PART OF THE HERDIA WAS EVIDENCED, A CURE WAS PERFORMED, AND SAMPLES WERE TAKEN FOR CULTURE. ON (B)(6) 2022, SURGICAL DEBRIDEMENT AND NEW SAMPLING FOR CULTURE WAS CARRIED OUT. DEBRIDEMENT IS REPEATED ON (B)(6) 2022, PERFORMING DAIR WITH CHANGE OF MOVING PARTS. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445669 LOGIC PS INSERT SZ 1.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK UNK 10885862180759

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other| R