BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20577511 · Received October 31, 2024

    Report

    Report Number
    1038671-2024-04198
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    June 20, 2023
    Report Date
    October 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2647716, 02-010-01-0310 - LOGIC FEMORAL PS CEM RIGHT SZ 1; 4374842, 02-012-45-1010 - LGC TIBIAL FIT TRAY CEM SZ 1F / 1T; 4342730, 200-02-26 - THREE PEG PATELLA 26MM; 4454101, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; 4432082, 201-78-81 - 3" TROCAR, MOD. HEX 2PK; 4432089, 201-78-81 - 3" TROCAR, MOD. HEX 2PK. 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: PATIENT ID: (B)(6) RK REV. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS AFTER INITIAL IMPLANT. RIGHT KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR AND LOOSENING OF THE OPTETRAK POLYETHYLENE TIBIAL INSERT. THERE IS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. THERE ARE NO X-RAYS OR IMAGES PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE. (B)(6), 02-012-35-1009 - LOGIC TIBIA PS MOD INSRT SZ 1 9MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K033883. FDA RECALL Z-0021-2022. CONCOMITANTS: 2647716, 02-010-01-0310 - LOGIC FEMORAL PS CEM RIGHT SZ 1; 4374842, 02-012-45-1010 - LGC TIBIAL FIT TRAY CEM SZ 1F / 1T; 4342730, 200-02-26 - THREE PEG PATELLA 26MM; 4454101, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; 4432082, 201-78-81 - 3" TROCAR, MOD. HEX 2PK; 4432089, 201-78-81 - 3" TROCAR, MOD. HEX 2PK. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT CASE IS FROM THE UNITED STATES. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABILITY DETERMINATION WILL BE ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983685 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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