BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

    MDR report key: 19706081 · Received July 9, 2024

    Report

    Report Number
    1038671-2024-02332
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023421
    PMA / PMN Number
    K070479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE MOST LIKELY CAUSE FOR THE REPORTED PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN HHE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICES: 4525626 162-00-05 - NECK PRESERVING STEM, STD OFFSET PLASMA SZ 5. 4767183 170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM. 4769004 186-01-56 - INTEGRIP CC, CLUSTER 56MM,G3. 4775301 180-65-30 - ALTEON 6.5MM SCREW, 30MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1729-2022 132-36-53 - NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS SERIAL: (B)(6). 510K: K070479. UDI: (B)(4) PRODUCT CODE: JDI, LPH, LWJ, LZO, MEH X-RAY: NO OPERATIVE NOTES: NO. CONCOMITANT DEVICES: 4525626 162-00-05 - NECK PRESERVING STEM, STD OFFSET PLASMA SZ 5. 4767183 170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM. 4769004 186-01-56 - INTEGRIP CC, CLUSTER 56MM,G3. 4775301 180-65-30 - ALTEON 6.5MM SCREW, 30MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973758 NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862023421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown