BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 18419982 · Received December 29, 2023

    Report

    Report Number
    1038671-2023-03078
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    December 8, 2023
    Report Date
    December 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 5801692, 02-010-01-0325 - LGC FEMORAL PS CEM RIGHT SZ 2.5; 5638680, 02-012-38-2511 - LOGIC RBK INSERT SZ 2.5, 11MM; 6052145, 02-012-43-2525 - LGC TIBIA RBKTRAY CEM SZ 2.5F/ 2.5T; 6056417, 201-78-81 - 3 TROCAR, MOD. HEX 2PK; 6026801, 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM; 5625159, 204-70-00 - TIBIAL STEM EXT. SCREW; S031361, 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED WITH KNEE PAIN. THE PATELLA WAS NOT TRACKING WELL IN THE TROCHLEAR GROOVE AND THE X-RAYS DID NOT SHOW LYSIS. AFTER OPEN, THE PATELLA WAS WORN AND THE MENISCAL INSERT WAS INSPECTED AND REPLACED. ALTHOUGH THE INSERT WAS NOT TERRIBLE, THE UNDERSIDE OF THE INSERT WAS YELLOW IN COLOUR. THIS WAS DEALT WITH SUSPICION AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236516 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female SEE H10.