BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20532967 · Received October 25, 2024

    Report

    Report Number
    1038671-2024-04121
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    November 27, 2022
    Report Date
    October 25, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Description of Event or Problem · 0

    LEGAL CASE - USA: PATIENT ID: (B)(6) LK REV. REFER TO (B)(4) RK REV. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY REVISION ON (B)(6) 2007 AND THEN APPROXIMATELY 15 YEARS, 7 MONTHS LATER HAD A SURGICAL REVISION ON (B)(6) 2022. THE PATIENT HAD SIMULTANEOUS KNEE REPLACEMENTS AND REVISION PROCEDURES. REVISION OPERATIVE REPORT OF (B)(6) 2022- THE FEMORAL AND TIBIAL COMPONENTS WERE VERY WELL FIXED. POLYETHYLENE LINER EXCHANGE DONE. LEFT SIDE UPSIZED TO 13MM CCK. THE PATELLA COMPONENT DEMONSTRATED WEAR AND WAS REVISED. THERE WAS A MODERATE DEGREE OF INFLAMED AND THICKENED SYNOVIUM CONSISTENT WITH CHRONIC SYNOVITIS. THE PATELLAR COMPONENT WAS NOT LOOSE BUT HAD POLYETHYLENE WEAR. THERE WAS WEAR ON THE ANTERIOR ASPECT OF THE BOX FOR THE TIBIAL INSERT. PROCEDURE: THERE WAS THICKENED INFLAMED SYNOVIUM CONSISTENT WITH POLYETHYLENE PARTICULATE DEBRIS-INDUCED PROCESS. A STERILE DRESSING WAS APPLIED TO THE KNEE AND THE PATIENT TAKEN TO RECOVERY IN STABLE CONDITION. HOSPITAL CARE: ADMITTED (B)(6) 2022/DISCHARGED (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. EBI INITIAL SURGERY SEARCH - HSS - NO RESULTS. 208-23-11 - (B)(6) - CC TIBIAL INSERT SZ 3, 11MM; Z-0019-2022 / SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K954208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568630 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H