BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS

    MDR report key: 19709416 · Received July 10, 2024

    Report

    Report Number
    1038671-2024-02337
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    August 29, 2023
    Report Date
    February 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024329
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 AND MEDICAL DEVICE CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 5207638, 190-30-04 - ALT HA S CLR STD SZ 4; 5414381, 170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM; 5918747, 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2; 6201653, 101-05-20 - 3.2MM DRILL BIT 20MM 1PK; S038520, 180-65-20 - ALTEON 6.5MM SCREW, 20MM. 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 THAT APPROXIMATELY 46 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LEFT HIP PAIN, SNAPPING, SCARRING, AND IRRITATION; EVIDENCE OF POLYETHYLENE IRRITATION; CRACKING AND ECCENTRIC WEAR OF POLYETHYLENE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN SATISFACTORY CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281641 NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862024329

    Patients

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