BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19010049 · Received April 1, 2024

    Report

    Report Number
    1038671-2024-00698
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    April 28, 2023
    Report Date
    September 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173843
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. THERE IS NO OTHER ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    D4: ADDED CATALOG NUMBER, EXPIRATION DATE, SERIAL NUMBER, AND UDI. D10: (B)(6) 02-012-45-6050 - LGC TIBIAL FIT TRAY CEM SZ 6F / 5T. (B)(6) 02-010-01-0260 - LOGIC FEMORAL PS CEM LEFT SZ 6. (B)(6) 200-02-41 - THREE PEG PATELLA 41MM. G3: ADDED 510K NUMBER. H4: ADDED DEVICE MANUFACTURE DATE. H6: CORRECTED HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. 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 INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR, AND INSTABILITY 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050991 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173843

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Required Intervention SEE H11.| UNK.