BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS

    MDR report key: 17105811 · Received June 12, 2023

    Report

    Report Number
    1038671-2023-01313
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    March 17, 2023
    Report Date
    May 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    UDI-DI
    10885862023315
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-2133-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. UPDATED/ADDITIONAL INFORMATION ¿ 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 INFORMATION- A2, B1, B5, B6, B7, D1, D2A, D2B, D4 ALL, D10, G4 510K, H4, H6 HEALTH EFFECT - CLINICAL CODE & MEDICAL DEVICE PROBLEM CODE, H7, H8, & H9. D10-CONCOMITANTS NOVATION PRESS-FIT FEMORAL STEM, COBALT-CHROME FEMORAL HEAD, 32 MM, NOVATION CROWN CUP CLUSTER HOLE SHELL. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. NO OTHER INFORMATION IS AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION VIA LEGAL-PATIENT REVISED TO EXACTECH DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2023-PRELIMINARY DIAGNOSIS- SEVERE POLYETHYLENE WEAR OF THE RIGHT HIP. RIGHT REVISION TOTAL HIP REPLACEMENT OF BOTH COMPONENTS. INDICATIONS-75 YO PATIENT PRESENTED WITH WEAR AND EARLY OSTEOLYSIS AND PAIN AFFECTING THE RIGHT HIP. RADIOGRAPHS REVEALED SEVERE POLYETHYLENE WEAR OVER THE RECALLED POLYETHYLENE LINERS. THE PATIENT WAS TAKEN TO THE RECOVERY AREA IN STABLE CONDITION WITH NO COMPLICATIONS NOTED ABOUT THE SURGERY. HOSPITAL CARE TIME: ADMITTED ON (B)(6)2023/DISCHARGED ON (B)(6) 2023. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2009. APPROXIMATELY 12 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2023 DUE TO BUT NOT LIMITED TO POLYETHYLENE WEAR, INSTABILITY, OSTEOLYSIS, AND COMPONENT LOOSENING. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267961 NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862023315
    783253 NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862023315

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention