BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC FEMORAL SZ 3

    MDR report key: 20417681 · Received October 10, 2024

    Report

    Report Number
    1038671-2024-03912
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    October 17, 2018
    Report Date
    October 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862053220
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. 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 - DENA MARTIN LK REV 2 (B)(4). IT WAS REPORTED FROM THE LEGAL DEPARTMENT THAT ON (B)(6) 2018, A PATIENT UNDERWENT A SECOND REVISION OF THE LEFT EXACTECH KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR, APPROXIMATELY 6 YEARS 4 MONTHS AFTER THE FIRST REVISION. IT IS STATED THAT DESPITE UNDERGOING THE REVISION SURGERIES, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6) 204-23-15 - PS TIBIAL INSERTS SZ 3, 15MM FDA RECALL Z-0019-2022 ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K933610 CONCOMITANTS: (B)(6) 208-01-03 - CC FEMORAL SZ 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004952 CC FEMORAL SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862053220

    Patients

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