BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19508803 · Received June 11, 2024

    Report

    Report Number
    1038671-2024-01878
    Event Type
    Injury
    Date Received
    June 11, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024275
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 5912170 (B)(6)- INTEGRIP CC,CLUSTER HOLE Ø 50. 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.

    Additional Manufacturer Narrative · 0

    H3: THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR COULD INCLUDE A NUMBER OF VARIABLES INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. ADDITIONALLY, INCREASED SHELF OXIDATION RESULTING FROM THE USE OF NYLON VACUUM BAGS WITHOUT EVOH COULD ALSO HAVE CONTRIBUTED TO THE WEAR. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO CLINICAL DATA WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    B1 - FIELDS ARE BLANK, NO ADVERSE EVENT AND NO PRODUCT PROBLEM. H6 - FIELDS UPDATED (REMOVED FAILURE OF IMPLANT CODE 1924).

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 42 MONTHS AFTER A TOTAL HIP REPLACEMENT PROCEDURE, THE PLAINTIFF MAY REQUIRE A FUTURE REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE PLAINTIFF HAS ALSO REPORTED PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813839 NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862024275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11