BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENTED FINNED TIB. TRA SZ 3F/3T

    MDR report key: 21251849 · Received January 28, 2025

    Report

    Report Number
    1038671-2025-00471
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    October 15, 2021
    Report Date
    January 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039736
    PMA / PMN Number
    K932776
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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. D10 CONCOMITANT DEVICES: (B)(6), 13A2101 - CEMEX SYSTEM FAST GENTA 70G. (B)(6), 200-03-32 - ONE PEG PATELLA 32MM. (B)(6), 201-78-78 - 4" DRILL BIT, HEX, 2 PK. (B)(6), 232-02-03 - OPTETRAK ASY, CR POROUS FEMORAL, SZ 3, LEFT. (B)(6), ASA0030 - STERILE DISPOSABLE CONTAINERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 101 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, METALLOSIS, PAIN, JOINT LAXITY, JOINT INSTABILITY, OSTEOLYSIS ON THE MEDIAL FEMORAL CONDYLE, AND TIBIAL BONE LOSS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE." THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0019-2022. 200-73-11 - CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++ SERIAL: (B)(6). 510K: K932690. UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: YES. CONCOMITANT DEVICES: (B)(6) 13A2101 - CEMEX SYSTEM FAST GENTA 70G. (B)(6) 200-03-32 - ONE PEG PATELLA 32MM. (B)(6) 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T. (B)(6) 201-78-78 - 4" DRILL BIT, HEX, 2 PK. (B)(6) 232-02-03 - OPTETRAK ASY, CR POROUS FEMORAL, SZ 3, LEFT. (B)(6) ASA0030 - STERILE DISPOSABLE CONTAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502393 CEMENTED FINNED TIB. TRA SZ 3F/3T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 3F/3T 10885862039736

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female SEE H11