BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 22141311 · Received June 4, 2025

    Report

    Report Number
    1038671-2025-02234
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    July 22, 2021
    Report Date
    June 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 5063178 - 02-022-44-4013 - TRULIANT TIB IMP PSC INSERT SZ 4, 13MM. 6673570 - 02-010-06-0240 - LOGIC CC FEMORAL SIZE 4, LEFT. 6018494 - 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM. 6765266 - 02-012-61-4000 - LOGIC OFFSET STEM EXT COUPLER 4MM. 5132191 - 02-012-64-1612 - TRU FLUTED STM EXT 16MM X120MM BLAST. 6693763 - 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-00213. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INFECTION AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 AND RADIOGRAPHS WERE 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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, H6. MDR SECTION CODES UPDATED/CORRECTED: E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INFECTION AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 AND RADIOGRAPHS WERE NOT PROVIDED. 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 APPROXIMATELY 67 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, UNDERWENT A REVISION PROCEDURE. APPROXIMATELY 1 MONTH POST REVISION PROCEDURE, AND THE PATIENT UNDERWENT A SECOND REVISION PROCEDURE TO ADDRESS PAIN, RECURRENT EFFUSIONS, AND AN INFECTION. PRE-SURGERY, THE PATIENT'S KNEE WAS ASPIRATED. HIS CELL COUNT WAS FOUND TO BE 38,500 AND HE WAS GROWING STAPHYLOCOCCUS LUGDUNENSIS. REVISION OPERATIVE NOTES WERE PROVIDED. THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT AND POLYETHYLENE EXCHANGE. THE PATIENT TOLERATED THE PROCEDURE WELL, THERE WERE NO COMPLICATIONS, AND HE WAS TRANSFERRED TO THE PACU IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530895 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention