BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR

    MDR report key: 18494183 · Received January 11, 2024

    Report

    Report Number
    1038671-2024-00079
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    July 18, 2016
    Report Date
    October 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862024282
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10. H3. INVESTIGATION RESULTS - THE PATIENT/GXL ACETABULAR LINER INVOLVED IN WAS REPORTED AS A PENDING REVISION DUE TO EARLY PROSTHESIS WEAR APPROXIMATELY 6.5 YEARS AFTER THE INDEX SURGERY. BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR/OSTEOLYSIS: IMPLANTED WITH A LATERALIZED LINER. THE MOST LIKELY CAUSE FOR THE PENDING REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 4232090 - 180-01-54 - CROWN CUP,CLUSTER-HOLE GR.54 -COMPETITOR FEMORAL NECK PROSTHESIS, SN (B)(6). PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA OUS LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT ON (B)(6) 2016. BASED ON THE SUBSEQUENT FINDINGS AND EXAMINATIONS CARRIED OUT BY THE HOSPITAL, IT WAS DETERMINED THAT THE PROSTHETIC HEAD NEEDED TO BE REVISED. THE PATIENT HAS ADVANCED COXARTHROSIS. THE PATIENT IS SCHEDULED TO HAVE REVISION SURGERY ON (B)(6) 2024. NO REVISION AT THIS TIME. THERE IS NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646373 NV GXL LNR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO EXACTECH, INC. 10885862024282

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male SEE H10.