BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH NOVATION CROWN CUP AND LINERS

    MDR report key: 20125475 · Received September 3, 2024

    Report

    Report Number
    1038671-2024-03217
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    June 5, 2023
    Report Date
    November 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022165
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4310307 180-01-54 - NV CROWN CUP CLSTR HOLE 54MM GROUP 2. 4793632 170-32-03 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +3.5MM. 4821700 180-65-35 - ALTEON 6.5MM SCREW, 35MM. 4927300 180-65-25 - ALTEON 6.5MM SCREW, 25MM. 4999457 164-01-13 - ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 13. 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.

    Additional Manufacturer Narrative · 0

    D1: CORRECTED THE FOLLOWING: BRAND NAME. H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS IS A COMBINATION OF THE RISK FACTORS SPECIFIED SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL). HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 69 MONTHS AFTER A LEFT HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ADVERSE LOCAL TISSUE REACTION, SYNOVITIS, OSTEOLYSIS, SUPERIOR WEAR OF THE RIM. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899620 EXACTECH NOVATION CROWN CUP AND LINERS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022165

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| H SEE H11