BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 5, 9MM

    MDR report key: 16633099 · Received March 28, 2023

    Report

    Report Number
    1038671-2023-00532
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    June 29, 2021
    Report Date
    July 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048462
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 5100479 200-02-38 - THREE PEG PATELLA 38MM. Z-0019-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INFECTION, FEMORAL LOOSENING, AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE 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

    AS REPORTED BY LEGAL NOTIFICATION, THIS MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2011. THE PATIENT UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2018 SECONDARY TO POLYETHYLENE LINER WEAR. THE PATIENT UNDERWENT A SECOND REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2021 SECONDARY TO POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS OF THE FEMORAL COMPONENTS. RELATED TO 1038671-2023-00530.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008023 PS TIBIAL INSERTS SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 204-25-09 10885862048462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10