BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 4, 9MM

    MDR report key: 19165130 · Received April 23, 2024

    Report

    Report Number
    1038671-2024-00950
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    April 17, 2019
    Report Date
    October 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048387
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 04241 203-96-10 - (11-2325) STRYKER 2000 90X13MM .050" 1.27MM. 1921191 201-78-10 - HOLDING PIN HEADED LONG 2 PACK. 1937255 201-78-10 - HOLDING PIN HEADED LONG 2 PACK. 2301788 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 2482444 204-04-44 - TRAPEZOID TIBIAL TRAY SZ 4F/4T. 2487745 200-02-35 - THREE PEG PATELLA 35MM. 2490745 234-03-04 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4. 2W531 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050). 04241 203-96-10 - (11-2325) STRYKER 2000 90X13MM .050" 1.27MM. H7: RECALL NUMBER (Z-0019-2022). H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT. THE CAUSE OF PROSTHESIS WEAR IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FRACTURE, DISASSEMBLY, AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR, FRACTURE, AND DISASSEMBLY COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE PROCEDURE ON (B)(6) 2012 AND THEN IT WAS REVISED ON (B)(6) 2019. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, FRACTURE OF THE TIBIAL COMPONENT, FAILURE OF THE POLYETHYLENE INSERT LOCKING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272946 PS TIBIAL INSERTS SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862048387

    Patients

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