BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRIP CC, CLUSTER 56MM,G3

    MDR report key: 21458550 · Received February 25, 2025

    Report

    Report Number
    1038671-2025-01191
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    April 29, 2024
    Report Date
    February 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862038791
    PMA / PMN Number
    K102975
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. D10 CONCOMITANT DEVICES: (B)(6), 132-40-53 - NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS. (B)(6), 188-01-07 - WEDGE PLASMA X/O SZ 7. (B)(6), 170-40-03 - BIOLOX DELTA FEMORAL HEAD 40MM 0D, +3.5MM. (B)(6), 180-65-30 - ALTEON 6.5MM SCREW, 30MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL THA, THE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS AND POLY WEAR. THE POLY WAS IN SEVERAL PIECES. NO ISSUES WITH SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088113 INTEGRIP CC, CLUSTER 56MM,G3 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. INTEGRIP CC, CLUSTER 56MM,G3 10885862038791

    Patients

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