BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 40MM ID, GROUP 4 CUPS

    MDR report key: 18140311 · Received November 15, 2023

    Report

    Report Number
    1038671-2023-02781
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 24, 2023
    Report Date
    December 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207050
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 4881184 186-01-60 - INTEGRIP CC, CLUSTER 60MM, G4. 4884382 170-40-00 - BIOLOX DELTA FEMORAL 40MM OD, +0MM. 4917680 190-20-11 - ALT HA S NOCLR STD SZ 11.

    Additional Manufacturer Narrative · 0

    H3: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AS SPECIFIED IN THE HHE: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION DUE TO EARLY PROSTHESIS WEAR REPORTED IS A COMBINATION OF RISK FACTORS SPECIFIED IN THE HHE. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THE PATIENT MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS: IMPLANTED WITH A LATERALIZED LINER, COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED, AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS MAY HAVE BEEN A COMBINATION OF RISK FACTORS SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL). HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    THE PATIENT HAD AN ORIGINAL EXACTECH PRIMARY TOTAL HIP REPLACEMENT ON (B)(6) 2017 BY DR. (B)(6). THE PATIENT RETURNED TO DR. WILLIAMS'S OFFICE HAVING BEEN NOTIFIED OF ORIGINALLY BEING IMPLANTED WITH A RECALLED HIP POLY LINER. THE PATIENT WAS BOOKED FOR REVISION THA POSSIBLE FEMORAL HEAD AND ACETABULAR POLY LINER SWAP ON (B)(6) 2023. THE PATIENT HAD A FEMORAL HEAD AND POLY LINER SWAP. IT WAS NOTED THAT THE REMOVED RECALLED LINER SHOWED EARLY ABNORMAL ECCENTRIC WEAR. THE PATIENT LEFT THE OR STABLE. DURING THIS CASE THE FEMORAL HEAD IMPACTOR TIP HAD A PIECE THAT BROKE OFF OF IT WHEN USING THE INSTRUMENT TO DISENGAGE THE FEMORAL HEAD FROM THE NECK TAPER. PICTURES OF THE BROKEN INSTRUMENT ARE ATTACHED. IT WILL BE RETURNED AND A NEW ONE ORDERED TO REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298885 NV GXL LINER LIPPED 40MM ID, GROUP 4 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862207050

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male