BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20189287 · Received September 11, 2024

    Report

    Report Number
    1038671-2024-03437
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    June 14, 2023
    Report Date
    October 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159236
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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.

    Additional Manufacturer Narrative · 0

    1038671-2024-03992 D4: ADDED CATALOG NUMBER, EXPIRATION DATE, SERIAL NUMBER, AND UDI D10: 4842509 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T. 4933234 02-010-03-0325 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2.5. 4995059 200-02-29 - THREE PEG PATELLA 29MM. G3: ADDED 510K NUMBER: H4: ADDED DEVICE MANUFACTURE DATE. H6: CORRECTED HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE, AND TYPE OF INVESTIGATION. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR AND LOOSENING COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    LEGAL CASE ¿ (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, CONSTRAINED LINER REVISION, POLYETHYLENE LINER FRAGMENTATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539030 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862159236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.| UNK.