BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 22961665 · Received September 4, 2025

    Report

    Report Number
    1038671-2025-02877
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    September 10, 2023
    Report Date
    September 4, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: (B)(6), 204-70-00 - TIBIAL STEM EXT. SCREW. (B)(6), 200-02-38 - THREE PEG PATELLA 38MM. (B)(6), 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4. (B)(6), 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T. (B)(6), 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO THE REPORTED INSTABILITY AND PROSTHESIS WEAR, OR INCLUSION OF THE POLYETHYLENE IMPLANTS IN THE PACKAGING RECALL. POSSIBLE CAUSES FOR POLYETHYLENE DAMAGE INCLUDE MALALIGNMENT BETWEEN IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, OR ANY COMBINATION OF THESE POSSIBILITIES. INSTABILITY MAY BE THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESIS. 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 A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED AND THEN UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. REASON FOR REVISION INDICATED INSTABILITY WITH THE PATELLA, CLICKING, AND THE POLY RECALL. THE PATIENT WAS REVISED TO A SIZE 4 CONSTRAINED FEMUR WITH AN 18 X 1 20 STEM A MEDIUM 32 CONE AND A 4\19 MM CONSTRAINED POLY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE NOT MADE AVAILABLE. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. DEVICE IMAGES, EBI SURGERY RESULTS, & QAD SERIAL TRACE ATTACHED. NO X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293575 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R SEE H11.