BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM

    MDR report key: 19811157 · Received July 23, 2024

    Report

    Report Number
    1038671-2024-02491
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    October 26, 2023
    Report Date
    April 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174512
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: ADDED CATALOG NUMBER, EXPIRATION DATE, SERIAL NUMBER, AND UDI D10: 5035887 , 02-010-03-0240 - LOGIC CR FEMORAL CEM, LEFT, SZ 4. 4233734 , 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. 5041199 , 200-02-41 - THREE PEG PATELLA 41MM. 5073914 , 201-78-81 - 3" TROCAR, MOD. HEX 2PK. G3: ADDED 510K NUMBER. H4: ADDED DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED BUT MAY BE DUE TO THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. THE TIBIAL INSERT WAS PACKAGED IN A NON-CONFORMING BAG FOR MORE THAN 5 YEARS, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE REPORTED WEAR AND DELAMINATION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS COULD NOT BE ASSESSED AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    LEGAL CASE ¿ USA (MASTER CASE NO. (B)(6)) THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO.(B)(6). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467054 LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.