BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21478374 · Received February 27, 2025

    Report

    Report Number
    1038671-2025-01282
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    September 25, 2024
    Report Date
    February 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. D10 CONCOMITANTS: (B)(6), 180-01-48 - NV CROWN CUP CLSTR HOLE 48MM GROUP 1, (B)(6), 180-65-25 - ALTEON 6.5MM SCREW, 25MM, (B)(6), 188-01-05 - WEDGE PLASMA X/O SZ 5, (B)(6), 188-01-06 - WEDGE PLASMA X/O SZ 6.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 85 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, POLYETHYLENE WEAR, SOFT TISSUE DAMAGE, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING; DAILY PAIN AND DISCOMFORT, LIMITED HER ACTIVITIES OF DAILY LIVING, IMPACTED QUALITY OF LIFE; SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; OSTEOLYSIS, ONGOING MEDICAL CARE. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617620 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11