BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

    MDR report key: 16751128 · Received April 17, 2023

    Report

    Report Number
    1038671-2023-00555
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207029
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 2974812 142-32-00 - COCR FEM HEAD 32MM +0 OFFSET 12/14, 3679309 188-01-04 - WEDGE PLASMA X/O SZ 4, 3767657 180-01-50 - NV CROWN CUP CLSTR HOLE 50MM GROUP 1, 3951396 101-05-30 - 3.2MM DRILL BIT30MM 1PK. H7: Z-1732-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, C, D, E, G. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION REPORTED IS PROSTHESIS WEAR AND 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 FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THE FEMALE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2015. THE PATIENT UNDERWENT PAINFUL AND RISKY REVISION SURGERY ON (B)(6)-2023 TO REMOVE THE GXL LINER. THE PATIENT HAD ENDURED AND CONTINUES TO ENDURE A PAINFUL RECOVERY AND REHABILITATION PROCESS FROM HER REVISION SURGERY. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818430 NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 132-32-51 10885862207029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10