BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS

    MDR report key: 16929499 · Received May 15, 2023

    Report

    Report Number
    1038671-2023-00988
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    October 30, 2017
    Report Date
    January 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024275
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED/ ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED/ADDED: B3, H6: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION REPORTED IS A COMBINATION OF 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). DISASSOCIATION OF THE LINER AND SUBSEQUENT WEAR OF THE ACETABULAR CUP AND FEMORAL HEAD MAY HAVE BEEN DUE TO EXTENSIVE WEAR OF THE LINER OR INCOMPLETE SEATING OF THE LINER AT THE TIME OF IMPLANTATION, WHICH ALLOWED FOR UNINTENDED CONTACT BETWEEN THE HEAD AND CUP. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION, AND THE DEVICES, IMAGES, AND RADIOGRAPHS WERE NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2000897, 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG. 1933978, 164-01-11 - ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 11. 2000167, 170-32-93 - BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM. 1873093, 180-01-50 - NV CROWN CUP CLSTR HOLE 50MM GROUP 1. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, IMPACT CODE, MEDICAL PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION DUE TO PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED THE PATIENT'S MOBILITY AND QUALITY OF LIFE AND NECESSITATED A REVISION SURGERY AND THE RESULTANT PAIN FOLLOWING SURGERY AND RECUPERATION/REHABILITATION PERIOD AND PHYSICAL THERAPY. 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
    32675 NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS UNK 10885862024275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10.