BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 23571540 · Received November 17, 2025

    Report

    Report Number
    1038671-2025-03340
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023421
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6), 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3, (B)(6), 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3, (B)(6), 101-05-30 - 3.2MM DRILL BIT30MM 1PK, (B)(6), 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM, (B)(6), 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM, (B)(6), 180-65-30 - ALTEON 6.5MM SCREW, 30MM, (B)(6), 180-65-30 - ALTEON 6.5MM SCREW, 30MM, (B)(6), 188-00-08 - WEDGE PLASMA S/O SZ 8, (B)(6), 188-00-08 - WEDGE PLASMA S/O SZ 8. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND STIFFNESS. UPON PHYSICAL AND X-RAY EXAMINATION, BOTH HIPS SHOW POLY THINNING, INDICATING POLY WEAR AND OSTEOLYSIS BEHIND THE ACETABULAR CUP IMPLANT, WHERE THE ACETABULAR SCREW IS LOCATED. A CT SCAN WAS ALSO OBTAINED, WHICH SHOWS THE SAME RESULTS. THERE IS CONCERN FOR LOOSENING OF THE ACETABULAR CUP IMPLANT. THE POLY LINER IS PART OF THE RECALL. THE SURGEON PLANNED FOR HEAD/LINER EXCHANGE WITH AUGMENTATION OF BONE GRAFT BEHIND THE CUPS VS. A FULL CUP REVISION. THE HIP JOINTS WERE EXPOSED, DEBRIDED, THE FEMORAL HEAD REMOVED. THEY CHECKED THE FEMORAL STEM FOR STABILITY, REMOVED THE ACETABULAR POLY LINER, REMOVED THE 6.5 X 30MM SCREW, AND THEN INJECTED A BONE VOID FILLER SUBSTITUTE INTO THE BONE DEFECT BEHIND THE CUP. THE HIP JOINTS WERE IRRIGATED AND DEBRIDED WELL. SURGEON IMPLANTED NEW POLY ACETABULAR LIPPED 40MM VITAMIN E LINER AND A 40MM +0 FEMORAL HEAD. THE PATIENT LEFT THE OR STABLE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289510 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 55 YR Male Hospitalization SEE H11