BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE IMPLANT

    MDR report key: 19491911 · Received June 7, 2024

    Report

    Report Number
    1038671-2024-01835
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    December 9, 2020
    Report Date
    June 7, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001894
    PMA / PMN Number
    K033883
    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: 4035065 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4 4006067 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 3943022 200-02-38 - THREE PEG PATELLA 38MM 49138 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050) 55138 203-96-03 - (11-2216) SAW BLADE NEW STRYKER (.050) 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

    IT WAS REPORTED THAT APPROXIMATELY 62 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SORENESS AND PAIN. THE PATIENT EXPERIENCED FUNCTIONAL LIMITATIONS WITH SLEEPING, DESCENDING STAIRS, WALKING, SQUATTING, KNEELING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319755 KNEE IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11