BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 23312764 · Received October 16, 2025

    Report

    Report Number
    1038671-2025-03130
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    July 1, 2025
    Report Date
    October 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, G3, H6, H11. MDR SECTION CODES UPDATED/CORRECTED: A. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. 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.

    Additional Manufacturer Narrative · 0

    D10: 204-36-08 - STEM EXTENSION 80L X16 MM 3546751. 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM 3557624. 208-07-03 - CC POSTERIOR FEM AUGMENT SZ 3, 5MM 3647989. 204-63-88 - TIBIAL AUGMENT BLOCK 1/2-SZ 3 11MM RLLM 3801515. 208-07-03 - CC POSTERIOR FEM AUGMENT SZ 3, 5MM 3808653. 208-23-18 - CC TIBIAL INSERT SZ 3, 18MM 3814355. 208-01-03 - CC FEMORAL SZ 3 4345100. 208-04-33 - TRAP TRAY, OFFSET ALPHA CEM., SZ 3F/3T 4408465. 204-36-12 - STEM EXTENSION W/SLOT 120L X16 MM 4491837. 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM 4871606. 208-04-76 - SCREW, OFFSET, SZHH 5174704. 204-63-89 - TIBIAL AUGMENT BLOCK 1/2-SZ 3 11MM LLRM 5193027. 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE 5371731. 200-02-29 - THREE PEG PATELLA 29MM 5580103. 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 COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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. 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 THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN SIDE. SUBSEQUENTLY, THE PATIENT REPORTED THAT THEY EXPERIENCED AN INFECTION DUE TO DEFECTIVE IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 6 YEARS AND 7 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374316 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R SEE H11.