BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 20866107 · Received December 6, 2024

    Report

    Report Number
    1038671-2024-04670
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    June 28, 2022
    Report Date
    February 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B3 - REMOVE DATE OF EVENT, H6 IMPACT CODE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5, D10. D10: 3848666 204-38-08 - STEM EXTENSION 80L X18 MM, 4062162 208-01-04 - CC FEMORAL SZ 4, 4070386 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 4085219 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE, 4201145 201-78-88 - 4"" DRILL BIT, MOD. HEX 2-PK.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. D10: (B)(6), 204-38-08 - STEM EXTENSION 80L X18 MM, (B)(6), 208-01-04 - CC FEMORAL SZ 4, (B)(6), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (B)(6), 208-09-05 - CC STEM EXT ADAPTOR 5 DEGREE, (B)(6), 201-78-88 - 4"" DRILL BIT, MOD. HEX 2-PK.

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE DISREGARD THIS REPORT AS IT WAS REPORTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT #1038671-2024-01434 AND 1038671-2024-04661.

    Description of Event or Problem · 0

    THE PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE LEFT KNEE AT ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 99 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085585 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization