BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    MDR report key: 17682914 · Received September 5, 2023

    Report

    Report Number
    1038671-2023-02151
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 18, 2022
    Report Date
    April 23, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS - PRODUCT INFORMATION: 4570964 170-32-03 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +3.5MM; 3852211 180-01-48 - NV CROWN CUP CLSTR HOLE 48MM GROUP 1; 4554903 180-65-20 - ALTEON 6.5MM SCREW, 20MM; 4662338 180-65-25 - ALTEON 6.5MM SCREW, 25MM; 4644734 188-01-05 - WEDGE PLASMA X/O SZ 5. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE NOT CONFIRMED WITH THE INFORMATION PROVIDED; DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE- ADDITIONAL INFORMATION/ B5, B7, H6. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Description of Event or Problem · 0

    REVISION OPERATIVE REPORT - POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOT HIP REPLACEMENT. PATIENT HAD REACTIVE LOCAL SYNOVITIS, WITH VILLONODULAR HYPERTROPHIC SYNOVIUM. NO EVIDENCE OF INFECTION. STEM WAS WELL FIXED. FEMORAL HEAD WAS REMOVED. THERE WAS WEAR SUPERIORLY AND SOME CRACKS DEVELOPING ON THE RIM AND DELAMINATION OF THE RIM. THE CUP WAS WELL FIXED AND IN GOOD POSITION. PATIENT WAS REVISED TO EXACTECH DEVICES. NO PATIENT DISPOSITION PROVIDED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2022. THE PATIENT HAS SUFFERED EXTREME PAIN, LOSS OF MOBILITY, LOSS OF INCOME, AND LOSS OF CONSORTIUM. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438372 NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1