BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    MDR report key: 18037351 · Received October 31, 2023

    Report

    Report Number
    1038671-2023-02633
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    May 31, 2023
    Report Date
    December 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207074
    PMA / PMN Number
    K110547
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4370283 142-32-03 - COCR FEM HEAD 32MM +3.5 OFFSET 12/14. 4349649 164-13-10 - NOVATION ELEMENT RO S/O COL SZ 10. 4210770 186-01-50 - INTEGRIP CC, CLUSTER 50MM, G1. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, E4: REMOVED ERRONEOUS ENTRY, G2, H6: CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE NOT CONFIRMED WITH THE INFORMATION PROVIDED; DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    H10. UPDATED/ADDITIONAL INFORMATION ¿G1. G2. G4. H6. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE NOT CONFIRMED WITH THE INFORMATION PROVIDED; DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: POLYETHYLENE FAILURE. THE ANTERIOR PSUEDOCAPSULE WAS EXCISED, SIGNIFICANT SYNOVITIS ESPECIALLY SUPERIORLY, THIS IS ALL REMOVED. DRILL WAS THEN USED TO THE PLACE A DRILL HOLE ON THE POLYETHYLENE AND 4.5 MM SCREW WAS THEN USED TO REMOVE THE POLYETHYLENE. THE SCREW HOLES HAD A LITTLE BIT OF SYNOVIUM IN THE CUP, BUT THERE WERE NO EVIDENCE OF CYSTS AND THE CUP WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341957 NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| H SEE H10.