BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, NEUTRAL, 28MM ID, GROUP 2 CUPS

    MDR report key: 15855578 · Received November 23, 2022

    Report

    Report Number
    1038671-2022-01505
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    March 17, 2022
    Report Date
    February 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022073
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 861723, 118-01-02 - P-SERIES PF PLASMA COLLARLESS SZ 2 12/14, 1220840, 180-01-54 - NV CROWN CUP CLSTR HOLE 54MM GROUP 2, 1261810, 148-28-03 - 12/14 ZIRCONIA HEAD 28MM +3.5MM NECK, 1299899, 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG, 1311358, 120-65-30 - BONE SCREW 6.5MM DIA X 30MM LONG, 1318975, 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE ORIENTATION OF THE ACETABULAR CUP, EDGE LOADING/IMPINGEMENT, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO POLYETHYLENE WEAR AND OSTEOLYSIS AFTER BEING IMPLANTED FOR APPROXIMATELY 13.5 YEARS. ADDITIONAL CONTRIBUTING FACTORS TO THE REPORTED FAILURES MAY HAVE BEEN THE RESULT OF 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 AVAILABLE FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED AT THE TIME OF THIS EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. 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

    THE FOLLOWING SECTIONS WERE CORRECTED: H1. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE ORIENTATION OF THE ACETABULAR CUP, EDGE LOADING/IMPINGEMENT, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO POLYETHYLENE WEAR AND OSTEOLYSIS AFTER BEING IMPLANTED. ADDITIONAL CONTRIBUTING FACTORS TO THE REPORTED FAILURES MAY HAVE BEEN THE RESULT OF A COMBINATION OF THE RISK FACTORS: 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 AVAILABLE FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED AT THE TIME OF THIS EVALUATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3/G4, H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: C, D. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE ORIENTATION OF THE ACETABULAR CUP, EDGE LOADING/IMPINGEMENT, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO POLYETHYLENE WEAR AND OSTEOLYSIS AFTER BEING IMPLANTED. ADDITIONAL CONTRIBUTING FACTORS TO THE REPORTED FAILURES MAY HAVE BEEN THE RESULT OF A COMBINATION OF THE RISK FACTORS: 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 AVAILABLE FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED AT THE TIME OF THIS EVALUATION. 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

    IT WAS REPORTED VIA LEGAL THAT 14 YEARS POST OP THE INITIAL LEFT THA, THIS FEMALE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS AND POLY WEAR. SURGEON STATED "THE EXACTECH NOVATION ACETABULAR COMPONENT WAS WELL FIXED AND THERE WAS CATASTROPHIC WEAR OF THE POLY LINER". THE LEFT ACETABULAR COMPONENTS AND FEMORAL HEAD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249092 NV GXL LNR, NEUTRAL, 28MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 130-28-52 UNK 10885862022073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention