BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL

    MDR report key: 17487240 · Received August 9, 2023

    Report

    Report Number
    1038671-2023-01913
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 7, 2022
    Report Date
    November 16, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT - CLINICAL CODE & MEDICAL DEVICE PROBLEM CODE, H7, H8, & H9 D10. CONCOMITANTS: 142-32-93 - COCR FEM HEAD 32MM -3.5 OFFSET 12/14, (B)(6), 164-13-08 - NOVATION ELEMENT RO S/O COL SZ 8, (B)(6), 180-65-20 - ALTEON 6.5MM SCREW, 20MM 4081160 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1 (B)(6). PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND OSTEOLYSIS AS SPECIFIED IN THE HHE: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR AND OSTEOLYSIS IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN (B)(6). HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AS DEVICES, IMAGES, AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    REVISION OPERATIVE REPORT OF (B)(6) 2022- PATIENT WAS REVISED TO EXACTECH DEVICES. PRE-PROCEDURE DIAGNOSIS: FAILED RIGHT TOTAL HIP ARTHROPLASTY. PROCEDURE(S): REVISION RIGHT TOTAL HIP ARTHROPLASTY, ACETABULAR LINER, AND FEMORAL HEAD BALL WITH BONE GRAFTING OF PELVIS. INDICATION: THIS IS A 78-YEAR-OLD WOMAN WHO PREVIOUSLY UNDERWENT RIGHT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY. SHE SUBSEQUENTLY UNDERWENT EXCISION OF HETEROTOPIC BONE. FOLLOWING THAT SHE DEVELOPED RADIOGRAPHIC SIGNS OF OSTEOLYSIS AND WAS NOTED TO HAVE A RECALL POLYETHYLENE LINER. SHE HAS A MINIMAL PAIN IN HER HIP BUT HAS BEEN HAVING PROGRESSIVE LYSIS. FINDINGS: WELL-FIXED AND POSITIONED IMPLANTS. LYTIC LESION INVOLVING SUPERIOR ACETABULUM WITH CORTICAL PERFORATION OF POSTERIOR ILIUM, INTACT ANTERIOR AND POSTERIOR COLUMNS, ECCENTRIC POLYETHYLENE WEAR WITH INFLAMED SYNOVIUM. IMPERVIOUS DRESSING WAS THEN PLACED, AND THE PATIENT WAS POSITIONED SUPINE EMERGED FROM ANESTHESIA IN STABLE CONDITION. NO COMPLICATIONS. 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) 2015. APPROXIMATELY 6 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2022. 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
    1960583 NV GXL LINER NEUTRAL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862207074
    2013832 NV GXL LINER NEUTRAL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention SEE H10