BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 6, 11MM

    MDR report key: 15502083 · Received September 29, 2022

    Report

    Report Number
    1038671-2022-01191
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 7, 2022
    Report Date
    January 5, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048547
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 1387234, 201-78-81 - 3" TROCAR, MOD. HEX 2PK 1032806, 203-96-03 - (11-2216) SAW BLADE NEW STRYKER (.050) 85097, 203-96-10 - (11-2325) STRYKER 2000 90X13MM .050" 1.27MM 83319, 203-96-21 - (11-2714) STRYKER 2000 90X13/21X 1.9MM 89080, 204-01-06 - PS CEMENTED FEMORAL SZ 6 0783532, 204-04-65 - TRAPEZOID TIBIAL TRAY SZ 6F/5T 0976357, 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM 1377032, 204-70-00 - TIBIAL STEM EXT. SCREW 1388145,

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE IMPLANT IS APPROXIMATELY 13 YEARS OLD. THE CAUSE OF THE PAIN, INFLAMMATION, AND OSTEOLYSIS CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED VIA LEGAL THAT THIS MALE PATIENT IS EXPERIENCING SEVERE RIGHT KNEE PAIN, INFLAMMATION, AND OSTEOLYSIS, "AMONG OTHER THINGS DUE TO THE OPTETRAK TOTAL KNEE REPLACEMENT". IMPLANTED ON OR ABOUT (B)(6), 2009, THERE IS NO INDICATION OR MENTION OF REVISION SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT IS EXPERIENCING SEVERE PAIN, INFLAMMATION, AND OSTEOLYSIS, AMONG OTHER THINGS DUE TO THE OPTETRAK TOTAL KNEE REPLACEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL THAT THIS MALE PATIENT IS EXPERIENCING SEVERE RIGHT KNEE PAIN, INFLAMMATION, AND OSTEOLYSIS, "AMONG OTHER THINGS DUE TO THE OPTETRAK TOTAL KNEE REPLACEMENT". IMPLANTED ON OR ABOUT (B)(6), 2009, THERE IS NO INDICATION OR MENTION OF REVISION SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942442 PS TIBIAL INSERTS SZ 6, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 204-26-11 UNK 10885862048547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R SEE H10