BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE IMPLANT

    MDR report key: 20226652 · Received September 16, 2024

    Report

    Report Number
    1038671-2024-03536
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    January 11, 2022
    Report Date
    September 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    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: (B)(6) 02-010-01-0220 - LOGIC FEMORAL PS CEM LEFT SZ 2 (B)(6) 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2 (B)(6) 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T (B)(6) 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T (B)(6) 200-03-29 - ONE PEG PATELLA 29MM (B)(6) 200-03-29 - ONE PEG PATELLA 29MM 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 108 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DIFFICULTY WITH EVERYDAY ACTIVITIES, TROUBLE WALKING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386372 KNEE IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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