BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 16818061 · Received April 26, 2023

    Report

    Report Number
    1038671-2023-00845
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    July 1, 2022
    Report Date
    March 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: (B)(6), 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. (B)(6), 02-012-49-4009 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM. (B)(6), 200-02-38 - THREE PEG PATELLA 38MM. G4. 510K: K123687 K140302.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, AND LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1/D2A/D2B, D4, H4, H6 (B CODES) PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN UDI #, SERIAL #, EXPIRATION AND MANUFACTURED DATES UNKNOWN. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, ON OR ABOUT (B)(6) 2019, THIS PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HIS RIGHT KNEE. AT SOME POINT AFTERWARD, THE PATIENT PRESENTED TO THEIR DOCTOR FOR AN EVALUATION OF HIS RIGHT KNEE, AS HE HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. ON OR ABOUT (B)(6)2022, THE PATIENT UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE DUE TO IMPLANT LOOSENING AND SIGNIFICANT SYNOVITIS. DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THERE WAS "INFLAMMATORY SYNOVITIS INVOLVING THE SUPRAPATELLAR POUCH, MEDIAL AND LATERAL GUTTER" AND THAT THERE WAS "SOME EROSION AFFECTING THE MEDIAL AND LATERAL ASPECT OF THE POLYETHYLENE LINER" THE SUBSEQUENT POST-OPERATIVE DIAGNOSIS CONFIRMED THAT THE PLAINTIFF'S RIGHT TOTAL KNEE ARTHROPLASTY FAILED DUE TO SIGNIFICANT LOOSENING, WHICH IS RELATED TO THE FAILURE IN THE POLYETHYLENE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO FURTHER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336344 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-010-04-0340 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10