BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    MDR report key: 15348328 · Received September 2, 2022

    Report

    Report Number
    1038671-2022-01018
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 9, 2022
    Report Date
    June 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. PENDING DEVICE RETURN. CONCOMITANT MEDICAL PRODUCTS: NV CROWN CUP CONSTRAINING RING G, - 180-03-11, A020240; NV CROWN CUP CONSTRAINED LINER G1 28MM - 134-28-41, 7092276; BIOLOX OPTION ADAPTOR +3.5MM 12/14 - 170-50-03, 7271026; BIOLOX OPTION FEMORAL HEAD 28MM - 170-28-50, 7233893.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF SURGICAL REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. H7: Z-1732-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE CAUSE OF THE PATIENT¿S DISLOCATIONS AND SUBSEQUENT REVISION REPORTED IN CANNOT BE CONCLUSIVELY DETERMINED. THE REPORTED DISLOCATIONS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE THIRD BODY PROSTHESIS WEAR AND DAMAGE TO THE RIM OF THE ACETABULAR LINER OR FEMORAL NECK IMPINGEMENT MAY HAVE CONTRIBUTED TO THE DISLOCATIONS. HOWEVER, THIS CANNOT BE CONFIRMED AS THE ACETABULAR LINER WAS NOT RETURNED FOR EVALUATION AND THE PROVIDED RADIOGRAPHS DO NOT SHOW THE HIP IN A DISLOCATED POSITION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2016. THE PATIENT PRESENTED TO THE SURGEON WITH A HISTORY OF PREVIOUS AND CHRONIC DISLOCATION OF THE LEFT THA AND WAS ADMITTED WITH A DISLOCATED LEFT THA. THE PATIENT WAS REVISED ON (B)(6) 2022. THE PATIENT WAS DISLOCATED ALREADY SO THE SURGEON USED A COLD CHISEL TO REMOVE THE 32MM +0 HEAD. THE ACETABULUM CUP/LINER WAS EXPOSED. A DRILL AND THE LINER REMOVAL TOOL WAS USED TO REMOVE THE LINER. THE CUP WAS CHECKED WITH A BONE TAMP, AND APPEARED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826070 NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention SEE H10