BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV CROWN CUP CLSTR HOLE 52MM GROUP 2

    MDR report key: 12637106 · Received October 14, 2021

    Report

    Report Number
    1038671-2021-00538
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 24, 2021
    Report Date
    December 29, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862037015
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF A DETERIORATION OF THE BOND BETWEEN THE ACETABULAR CUP AND THE BONE AFTER BEING IMPLANTED FOR OVER 11 YEARS, WHICH LED TO ASEPTIC (NON-INFECTED) ACETABULAR LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION AND X-RAYS WERE NOT PROVIDED. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF "LOOSENING - ACETABULAR" IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE ACETABULAR COMPONENT AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE. SECTION D10: CONCOMITANT MEDICAL PRODUCTS NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS (CAT# 130-32-52 / SERIAL# (B)(6)) COCR FEM HEAD 32MM +0 OFFSET 12/14 (CAT# 142-32-00 / SERIAL# (B)(6))

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THIS (B)(6) YEAR OLD FEMALE PATIENT HAD A P-SERIES STEM WITH NOVATION CUP INSERTED ON AN UNKNOWN DATE, A LTK IMPLANTED APPROXIMATELY 10 YEARS AGO IN VIRGINIA. THE PATIENT EXPERIENCED ON GOING PAIN BEFORE CUP BECAME LOOSE AND SPUN OUT OF POSITION. P-SERIES STEM WAS RETAINED AND A NEW HEAD WAS PLACED ON THE WELL FIXED STEM. CUP WAS CHANGED TO A ZIMMER ACETABULAR CAGE COMPONENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE DEVICE WAS DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531186 NV CROWN CUP CLSTR HOLE 52MM GROUP 2 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV CROWN CUP CLSTR HOLE 52MM GROUP 2 UNK 10885862037015

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention