BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 35MM

    MDR report key: 17321306 · Received July 13, 2023

    Report

    Report Number
    1038671-2023-01656
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    August 6, 2019
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H11. UPDATED/ADDITIONAL INFORMATION ¿ D5. G1. G2. G4. H6. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS FRACTURE AND PROSTHESIS WEAR. 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. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS FRACTURE AND PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 1089349 204-24-11 - PS TIBIAL INSERTS SZ 4, 11MM. 1370380 201-78-81 - 3" TROCAR, MOD. HEX 2PK. 1520963 201-78-81 - 3" TROCAR, MOD. HEX 2PK. 1X233 203-90-03 - 11-3978 STABLECUT GTS OSC SYSTEM 6105X19X1.27. 24036 203-96-41 - (11-3974) STRYKER SYS 6 90X13X1.27. 27166 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19. 1562339 204-04-45 - TRAPEZOID TIBIAL TRAY SZ 4F/5T. 2343697 204-36-12 - STEM EXTENSION W/SLOT 120L X16 MM. 2021655 204-38-08 - STEM EXTENSION 80L X18 MM. 2371786 204-70-00 - TIBIAL STEM EXT. SCREW. 9171827 208-01-04 - CC FEMORAL SZ 4. 2003140 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM. 2099269 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM. 1892109 208-07-04 - CC POSTERIOR FEM AUGMENT SZ 4, 5MM. 2225801 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS MANUFACTURER NARRATIVE UPDATED: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS FRACTURE AND PROSTHESIS WEAR. 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. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS FRACTURE AND PROSTHESIS WEAR COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2012. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2019, APPROXIMATELY 6 YEARS 11 MONTHS AFTER THEIR PRIMARY PROCEDURE. THE PATIENT CLAIMS TO HAVE SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: PATELLAR COMPONENT SHATTERING, AND INTENSE PAIN. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766412 THREE PEG PATELLA 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 200-02-35 UNK 10885862039606

    Patients

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