BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALT XLE LNR NTRL G4 36

    MDR report key: 24948330 · Received April 21, 2026

    Report

    Report Number
    1038671-2026-00487
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 21, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862549563
    PMA / PMN Number
    K182502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 01-030-01-0450 - ALT CUP CLSTR G4 SZ 50: (B)(6) 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM: (B)(6) 188-01-03 - WEDGE PLASMA X/O SZ 3: (B)(6). 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

    AS REPORTED, APPROXIMATELY 3 YEARS AND 1 MONTH POST THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY, AND FOLLOWING MULTIPLE DISLOCATIONS AND PAIN, THE PATIENT WAS REVISED DUE TO INSTABILITY AND THE RECALLED LINER WAS REMOVED. STABILITY OF THE ACETABULAR COMPONENT WAS CHECKED AND FOUND TO BE ADEQUATE AND STABLE. A HIP ASPIRATION DEMONSTRATED NO GROWTH ON CULTURE AND WAS NOT INDICATIVE OF INFECTION. THE PATIENT WAS DISCHARGED HOME WITH HOME HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327698 ALT XLE LNR NTRL G4 36 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862549563

    Patients

    Seq Age Sex Outcome Treatment
    1