BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

    MDR report key: 15069801 · Received July 20, 2022

    Report

    Report Number
    1038671-2022-00824
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    June 30, 2022
    Report Date
    March 19, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    MEH
    UDI-DI
    10885862022165
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): CUP.

    Additional Manufacturer Narrative · 0

    SECTION H10: (D1) BRAND NAME: NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS (D4) CATALOG NUMBER: 130-32-52, SERIAL NUMBER: (B)(6) EXPIRATION DATE: 10-FEB-2020, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G5) PMA/510(K)NUMBER: K070479 (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF ECCENTRIC PROSTHESIS WEAR OF THE ACETABULAR LINER OVER 7 YEARS OF IMPLANTATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. (H4) DEVICE MANUFACTURE DATE: 13-FEB-2015 SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D10) CONCOMITANT DEVICE(S): 186-01-54, 3718125 - INTEGRIP CC, CLUSTER 54MM, G2 (H6) COMPONENT CODE: 734, BEARINGS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 73 Y/O MALE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE POLY WEAR. PATIENT HAD CUP AND LINER REMOVED AND A SMITH AND NEPHEW CERAMIC CUP AND LINER WERE IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT BE RETURNING, HOSPITAL THREW IT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400660 NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH EXACTECH, INC. UNK UNK 10885862022165

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention