BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 4, 9MM

    MDR report key: 18440561 · Received January 3, 2024

    Report

    Report Number
    1038671-2024-00013
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    December 4, 2023
    Report Date
    March 7, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048387
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, HIGH CONTACT STRESS, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO WEAR OF THE POLYETHYLENE INSERT AND PATELLA COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: 2025330 204-04-45, TIBIAL TRAY TRAPEZOID, CEMENTED ; 2232579 234-02-04, ASYMMETRIC FEMORAL POSTERIOR STABILIZED, CEMENTED SZ 4 LEFT ; 2228270 200-02-32, 3 PEG PATELLA, CEMENTED 32MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 75 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2012, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 11 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY ISSUES WITH FLAKING AND DELAMINATION. THEY WERE REVISED TO A 38MM PATELLA AND A SZ4, 11MM TIBIAL INSERT. THE SURGEON REMOVED THE FRAGMENTS OF POLYETHYLENE THAT WERE PRESENT IN THE KNEE JOINT. THERE WAS A 5¿15-MINUTE SURGICAL DELAY/PROLONGATION DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS WERE PROVIDED. NO DEVICE RETURNS AVAILABLE AS THEY WERE DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761018 PS TIBIAL INSERTS SZ 4, 9MM SEE H10 JWH EXACTECH, INC. UNK 10885862048387

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention