BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

    MDR report key: 19435727 · Received May 31, 2024

    Report

    Report Number
    1038671-2024-01646
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    June 8, 2023
    Report Date
    May 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 5044259 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM 4905370 180-01-58 - NV CROWN CUP CLSTR HOLE 58MM GROUP 3 4996278 180-65-25 - ALTEON 6.5MM SCREW, 25MM 4483759 180-65-35 - ALTEON 6.5MM SCREW, 35MM 4294850 188-01-12 - WEDGE PLASMA X/O SZ 12 THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-1729-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS THE CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 68 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS OSTEOLYSIS, PROSTHESIS WEAR, PAIN, DISCOMFORT, CLICKING/POPPING, SWELLING, GAIT IMPAIRMENT, POOR BALANCE, BONE LOSS, AND BONE DAMAGE. THE PATIENT ADDITIONALLY REPORTED EMOTIONAL DISTRESS. DURING THE PROCEDURE A LARGE OSTEOLYTIC CYST WAS FOUND, INCLUDING SYNOVITIS AND BROWN VILLONODULAR TISSUE.. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399416 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R SEE H10