BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM

    MDR report key: 16461237 · Received March 1, 2023

    Report

    Report Number
    1038671-2023-00300
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    June 23, 2023
    Report Date
    March 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173584
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION CONCOMITANT DEVICE(S): SERIAL #: (B)(4) CATEGORY #: CS-10CC - INTERSEP CALCIUM SULFATE, SERIAL #: (B)(4), CATEGORY #: 02-010-06-0531 - LOGIC POST. AUG. BLOCK SIZE 3, 5MM, SERIAL #: (B)(4), CATEGORY #: 02-012-60-1812 - LOGIC STEM EXT 18MM X 120MM, SERIAL #: (B)(4), CATEGORY #: 02-010-06-0330 - LOGIC CC FEMORAL SIZE 3, RIGHT, SERIAL #: (B)(4), CATEGORY #: 02-010-06-0531 - LOGIC POST. AUG. BLOCK SIZE 3, 5MM.

    Additional Manufacturer Narrative · 0

    H3: 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 PATIENT¿S PAIN 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D6B - EXPLANT DATE IS UNKNOWN. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. 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 AND RADIOGRAPHS 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 BY THE LEGAL DEPARTMENT THAT THIS MALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN, STIFFNESS, AND DISCOMFORT REQUIRING MEDICAL TREATMENT, MONITORING AND CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REVISION PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND UNDERWENT A SECOND REVISION PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123746 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862173584

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R SEE H10.| SEE H11.