BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 23492307 · Received November 6, 2025

    Report

    Report Number
    1038671-2025-03285
    Event Type
    Injury
    Date Received
    November 6, 2025
    Report Date
    November 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-020-11-0345 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5: 7048350. 02-022-35-4511 - TRULIANT TIB IMP PS INSERT SZ 4.5 11MM: 7206924. 02-022-45-4540 - TRULIANT TRAY, CEM SZ 4.5F/4T: 6923201. 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK: A031164. 203-96-64 - SAWBL EZ1913.M62 90X19, 1.27MM STRKR5/6/7: 028867. 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK: S364412. 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK: S303775. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. THE SURGEON REVISED THE PATELLA DUE TO WEAR AND PITTING. HE ALSO DID A POLY SWAP GOING FROM A 11MM TO 12MM PS POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299364 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization