BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 16585442 · Received March 21, 2023

    Report

    Report Number
    1038671-2023-00473
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    June 30, 2020
    Report Date
    January 28, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023438
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS, HAVE BEEN UPDATED ACCORDINGLY: H6: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED IN THIS CASE MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AS SPECIFIED IN THE HHE: IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SPECIFIED. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND IMAGES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 1. NOVATION ACETABULAR CUP, CATALOG NO. 180-01-60, LOT NO. 2530980; 2. NOVATION FEMORAL STEM, CATALOG NO. 160-33-16, LOT NO. 2973169; AND 3. FEMORAL HEAD, CATALOG NO. 142-36-00, LOT NO. 2996947. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2014. FOLLOWING A PERIOD OF POST-IMPLANTATION RECOVERY AND FOR YEARS AFTER THE REPLACEMENT SURGERY, THE PATIENT¿S EXACTECH HIP DEVICE PERFORMED AS EXPECTED. THE PATIENT UNDERWENT REVISION OF THE EXACTECH HIP DEVICE SECONDARY TO SIGNIFICANT POLYETHYLENE LINER WEAR RESULTING IN SYNOVITIS AND OSTEOLYSIS ON (B)(6) 2020, APPROXIMATELY 5 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. DESPITE UNDERGOING THE REVISION SURGERY, THE PATIENT EXPERIENCES DAILY HIP PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. THE PATIENT HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO ADDITIONAL REVISION SURGERIES; COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; AND PAIN AND SUFFERING. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12681 NOVATION PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID GROUP 4 CUPS UNK 10885862023438

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10.