BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

    MDR report key: 20430707 · Received October 11, 2024

    Report

    Report Number
    1038671-2024-03952
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    October 11, 2024
    Report Date
    February 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022066
    PMA / PMN Number
    K070479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: (B)(6) 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1 (B)(6) 186-01-50 - INTEGRIP CC, CLUSTER 50MM, G1 (B)(6) 180-65-30 - ALTEON 6.5MM SCREW, 30MM (B)(6) 180-65-30 - ALTEON 6.5MM SCREW, 30MM (B)(6) 190-30-03 - ALT HA S CLR STD SZ 3 (B)(6) 190-30-03 - ALT HA S CLR STD SZ 3 (B)(6) 170-28-00 - BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM (B)(6) 170-28-00 - BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM. 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 A 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

    BASED ON THE AVAILABLE INFORMATION, THE PATIENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS: IMPLANTED WITH A LATERALIZED LINER, COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS MAY HAVE BEEN 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). HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT CLINICAL CODES.

    Description of Event or Problem · 0

    LEGAL CASE ¿ USA (MDL NO. 3044). (B)(4) LH IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, AMBULATORY PROBLEMS, JOINT PAIN AND WEAKNESS, OSTEOLYSIS, PAST AND FUTURE MEDICAL EXPENSES, PAST AND FUTURE LOST WAGES, LOSS OF EARNING CAPACITY, MENTAL SUFFERING AND ANGUISH, PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. UNABLE TO CONFIRM SPECIFIC DEVICES DUE TO BILATERAL EBI INVOICE DATA. THE SERIAL NUMBER (B)(6) ARE CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1729-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294406 NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.