BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GXL NUETRAL LINER, G0 28MM ID

    MDR report key: 16777219 · Received April 20, 2023

    Report

    Report Number
    1038671-2023-00765
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    June 10, 2019
    Report Date
    January 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022059
    PMA / PMN Number
    K100269
    Removal / Correction Number
    Z-1731-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: CONCOMITANTS: 3859270 101-45-20 - 4.5MM DRILL BIT 20MM 3910769 142-28-00 - COCR FEM HEAD 28MM +0 OFFSET 12/14 4052026 180-01-46 - CUP, CLUSTER-HOLE, 46MM GROUP 0 4120925 164-13-09 - NOVATION ELEMENT RO S/O COL SZ 9 4215851 180-65-20 - ALTEON 6.5MM SCREW, 20MM.

    Additional Manufacturer Narrative · 0

    ADDED INFORMATION TO D7A. H6: INVESTIGATION RESULTS - THE PATIENT/GXL ACETABULAR LINER INVOLVED WAS REPORTEDLY REVISED DUE TO PROSTHESIS WEAR, SYNOVITIS, AND METALLOSIS APPROXIMATELY 3 YEARS AND 4 MONTHS AFTER THE INDEX SURGERY. HOWEVER, THE REVISED COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AS SPECIFIED IN THE HHE: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED, AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION DUE TO EARLY PROSTHESIS WEAR REPORTED IS A COMBINATION OF RISK FACTORS. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. INITIAL SUBMISSION: ALL FIELDS IN SECTION F SHOULD BE BLANK, THIS IS A MANUFACTURER'S REPORT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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

    PER A REPORT FROM THE LEGAL DEPARTMENT THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 3 YEARS AND 3 MONTHS AFTER THE INITIAL SURGERY THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2019 DUE TO A FAILED RIGHT HIP ARTHROPLASTY WITH ECCENTRIC POLYETHYLENE WEAR AND OSTEOLYSIS. THE DOCTOR NOTED IN THE REVISION OPERATIVE REPORT THAT "...DID A COMPLETE SYNOVECTOMY OF THE HIP JOINT DUE TO EXTREME SYNOVITIS AND MELLOSIS. AS I WAS DOING THIS, I NOTICED THAT THE CUP MOVED FORWARD AND THERE WAS EXTREME POLYETHYLENE FAILURE AND WEAR OF THE POLY." THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624622 GXL NUETRAL LINER, G0 28MM ID PROSTHESIS, HIP, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. GXL NUETRAL LINER, G0 28MM ID UNK 10885862022059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10