BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 3, 9MM

    MDR report key: 19621172 · Received June 26, 2024

    Report

    Report Number
    1038671-2024-02164
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 17, 2024
    Report Date
    May 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048301
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO THE PROSTHESIS WEAR AND INSTABILITY OR DUE TO THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. INSTABILITY MAY BE THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESIS. 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. 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

    D10: CONCOMITANTS: 1823634 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T. 1825598 234-03-03 - OPTETRAK ASY, PS CEMENTED FEMORAL, SZ 3.

    Description of Event or Problem · 0

    APPROXIMATELY 14 YEARS AFTER A RIGHT TOTAL KNEE REPLACEMENT, THE PATIENT RETURNED WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP AND PATELLA SWAP. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722935 PS TIBIAL INSERTS SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862048301

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention SEE H11