BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM

    MDR report key: 17612152 · Received August 24, 2023

    Report

    Report Number
    1038671-2023-02038
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    November 9, 2023
    Report Date
    February 2, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174581
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. H6. INVESTIGATION RESULT - THE REVISION REPORTED WAS LIKELY THE RESULT OF OSTEOLYSIS. THE EXTENT AND ROOT CAUSE OF THE OSTEOLYSIS COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. THERE IS NO OTHER INFORMATION PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION WAS RECEIVED/REQUIRES ADDITIONAL INVESTIGATION-ADDITIONAL/UPDATED INFORMATION ¿ B3, B5, D4 SN, EXP DATE, D6B, H4, H6 HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE. D10-DEVICES IDENTIFIED-CONCOMITANTS: SN (B)(6), 02-010-04-0250 LOGIC CR FEMORAL POR, LEFT, SZ 5. SN (B)(6), 02-012-45-5050 LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. SN (B)(6), 200-02-41 THREE PEG PATELLA 41MM. INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 0

    B3- DATE TO REPRESENT 2023-REVISION DATE OR INFORMATION WAS NOT PROVIDED. D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D4 INFORMATION- PATIENT HAS THE SAME SIZE AND STYLE POLYETHYLENE IMPLANTED IN BOTH KNEES. 02-012-48-5009 LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM IS BEING REPORTED IN PRODUCT INFORMATION WITH THE SERIAL NUMBER AS UNKNOWN BECAUSE THE INFORMATION PROVIDED DID NOT SPECIFY WHICH SERIAL NUMBER WAS IMPLANTED FOR THE LEFT OR THE RIGHT KNEE. LEFT AND RIGHT KNEE ARE MDR REPORTED. SN (B)(6); 02-012-48-5009 LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM- MFG DATE-17 NOV 2015/EXP DATE-16 NOV 2023. THIS IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. SN (B)(6); 02-012-48-5009 LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM-MFG DATE-30 MAR 2016/EXP DATE 29 MAR 2024. THIS IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. D10. ALL PRODUCTS LISTED IN CONCOMITANTS FOR BOTH KNEES, AS THERE WAS NO INFORMATION DIFFERENTIATING WHICH PRODUCT BELONGS TO THE LEFT OR THE RIGHT KNEE EXCEPT FOR THE FEMORAL COMPONENT. (B)(6) 02-010-04-0250 LOGIC CR FEMORAL POR, LEFT, SZ 5. (B)(6) 02-012-45-5050 LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. (B)(6) 02-012-45-5050 LGC TIBIAL FIT TRAY CEM SZ 5F / 5T. UNK 200-02-41 THREE PEG PATELLA 41MM. (B)(6) 200-02-41 THREE PEG PATELLA 41MM. (B)(6) 201-78-81 3" TROCAR, MOD. HEX 2PK. (B)(6) 521-78-23 THREADED PIN SIZE 2.3 COLLARED 2PK. (B)(6) 201-78-15 HOLDING PIN MINI SHARP POINT 4 PK. H3. THE LOGIC CR TIB INSERT DEVICES REPORTED WERE CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAGS THAT DO NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THE PATIENT HAS BILATERAL KNEE REPLACEMENTS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE ARTHROPLASTY REVISION ON (B)(6) 2023, APPROXIMATELY 7 YEARS, 1 MONTH AFTER IMPLANT DUE TO OSTEOLYSIS, ALL IMPLANTS WERE REMOVED. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICES. THERE WAS NO SURGICAL DELAY/PROLONGATION. THERE IS NO MEDICAL/CLINICAL HISTORY AVAILABLE. THERE ARE NO PHOTOS OR IMAGES AVAILABLE. THE DEVICE WILL NOT RETURN, IT WAS DISPOSED OF BY THE FACILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2016. IT IS REPORTED THAT THE PATIENT¿S LEFT KNEE HAS EXPERIENCED ONGOING COMPLAINTS SINCE THIS PROCEDURE REQUIRING REVISION SURGERY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100763 LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM SEE H10 JWH EXACTECH, INC. 10885862174581

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention SEE H10