BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM

    MDR report key: 17221901 · Received June 28, 2023

    Report

    Report Number
    1038671-2023-01493
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    March 16, 2017
    Report Date
    May 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173720
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE LOGIC TIBIA IMPLANT PSC INSERT WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT¿S PATELLAR CLUNK 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. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 3637617 02-010-01-0250 - LOGIC FEMORAL PS CEM LEFT SZ 5 3739344 200-02-35 - THREE PEG PATELLA 35MM 3767387 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T 132511 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS A20149144 620-12-02 - ACCELERATE PRP 60 ML & ACD-A PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND LOSS OF RANGE OF MOTION 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 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2014. APPROXIMATELY 2 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017 DUE TO PAIN AND DISCOMFORT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2017 DIAGNOSIS: PATELLAR CLUNK THERE WAS EXTENSIVE SCAR TISSUE AND AN EXTENSIVE DEBRIDEMENT WAS PERFORMED. THE PATIENT WAS TAKEN TO RECOVERY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254295 LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 11MM UNK 10885862173720

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention SEE H10