BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS

    MDR report key: 19341847 · Received May 17, 2024

    Report

    Report Number
    1038671-2024-01313
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 17, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207043
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: (B)(6) - 164-01-14 - ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 14 (B)(6) - 170-40-03 - BIOLOX DELTA FEMORAL HEAD 40MM 0D, +3.5MM (B)(6) - 180-01-56 - NV CROWN CUP CLSTR HOLE 56MM GROUP 3.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 7 YEARS AND 5 MONTHS POST THE INITIAL THA, THE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH COMPLAINTS OF THEIR LEFT HIP. THE PATIENT REPORTED PAIN, INSTABILITY, AND DISSATISFACTION. THE PATIENT HAD A RECALLED HIP LINER AND IT WAS SHOWN ON THE X-RAY TO HAVE WEAR AND FEMORAL HEAD MIGRATION WITHIN THE ACETABULAR IMPLANT. THE PATIENT WAS SCHEDULED FOR LEFT HIP REVISION POSSIBLE POLY LINER AND FEMORAL HEAD SWAP VS. FULL REVISION. THE PATIENT UNDERWENT LEFT HIP REVISION ON (B)(6) 2024. DURING THE REVISION, THE PATIENT PRESENTED WITH EXCESSIVE HIP POLY LINER WEAR, AND THE POLY LINER WAS FRACTURED. THE FEMORAL HEAD WAS CONTACTING THE METAL CUP AND CREATED METALLOSIS WITHIN THE HIP JOINT CAPSULE. THERE WAS OSTEOLYSIS BEHIND THE ACETABULAR CUP AND THE IMPLANTED PRESENTED TO BE LOOSE. THE ACETABULAR CUP WAS REMOVED, THE HIP JOINT WAS DEBRIDED FROM METALLOSIS TISSUE AND BONE, AND THE PATIENT REQUIRED AN ALLOGRAFT FEMORAL HEAD BONE GRAFTING SUBSTITUTE WITHIN THE ACETABULUM. A NEW ZB G7 MULTI-HOLE CUP WAS IMPLANTED WITH SCREWS AND A LATERALIZED HIP LINER. A 36MM +10 MM HEAD WAS IMPLANTED TO MATCH THE ZB COMPONENTS. THE SURGEON HAD TO MAKE UP LEG LENGTH WITH +10 AND A LATERALIZED LINER DUE TO THE METALIZATION OF THE FINAL CONSTRUCT AFTER REMOVAL AND REVISION RE-IMPLANT. THERE WAS A 15-30 MINUTE DELAY AND NO ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530986 NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862207043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention