BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21447347 · Received February 24, 2025

    Report

    Report Number
    1038671-2025-01162
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    January 15, 2023
    Report Date
    May 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANTS: 02-022-45-4545 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/4.5T: 7252610; 02-020-11-0245 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4.5: 7257669; 02-022-35-4509 - TRULIANT TIB IMP PS INSERT SZ 4.5 9MM: A049680; 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: A095188; 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: A138292; 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK: A244312; 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK: A245518; 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QCK REL: A247563. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXINS REPORT WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR SURGICAL PROCEDURE. ADDITIONALLY, INFECTION IS A KNOWN SURGICAL RISK, AS OUTLINED IN THE IFU. 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

    IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED APPROXIMATELY 1 MONTH POST INITIAL SURGERY. THE REVISION WAS DUE TO AN INFECTION AND A RUPTURE OF HIS KNEE IMPLANT AFTER UNDERGOING KNEE REPLACEMENT SURGERY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413017 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization SEE H11