BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ4, 9MM

    MDR report key: 20016546 · Received August 21, 2024

    Report

    Report Number
    1038671-2024-02937
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 28, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862040299
    PMA / PMN Number
    K932776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND/OR INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 1125322 - 200-02-35 - THREE PEG PATELLA 35MM 1194761 - 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK) 73135 - 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050) 0979109 - 204-04-43 - TRAPEZOID TIBIAL TRAY SZ 4F/3T 1210854 - 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM 1209322 - 204-70-00 - TIBIAL STEM EXT. SCREW 1172192 - 230-02-04 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4, 94629 - 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS 6003060806 - 620-11-02 - ACCELERATE CONC. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 179 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299999 CR TIBIAL INSERT SZ4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862040299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H11