BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    MDR report key: 15499627 · Received September 28, 2022

    Report

    Report Number
    1038671-2022-01178
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    July 20, 2022
    Report Date
    April 16, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. MEDICAL DEVICES: 120-65-35 - BONE SCREW 6.5MM DIA X 35MM LONG 3657311, 130-36-52 - NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS 2968392, 148-36-93 - 12/14 ZIRCONIA HEAD 36MM REP BY 170-36-93 2621477, 164-12-12 - NOVATION ELEMENT RO X/O SZ 12 2584998, 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2 3559875. (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 INVESTIGATION CODES ADDED. H6. BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR PROSTHESIS WEAR AS SPECIFIED IN THE HHE: SIGNIFICANT EDGE LOADING OF THE FEMORAL HEAD ON THE ACETABULAR LINER AND COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF THE RISK FACTORS. OXIDATION INDICES WERE MEASURED PER ASTM F2102-17 ON REAL-TIME AGED EXACTECH GXL HIP LINERS PACKAGED ACROSS A VARIETY OF VACUUM BAG LOTS. A PRELIMINARY ROOT CAUSE CANNOT BE DETERMINED AS A NUMBER OF VARIABLES INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL COULD HAVE ALL CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS RELATED COMPLAINTS. ADDITIONALLY, INCREASED SHELF OXIDATION RESULTING FROM THE USE OF NYLON VACUUM BAGS WITHOUT EVOH COULD ALSO HAVE CONTRIBUTED TO THE INCREASED TREND IN WEAR/OSTEOLYSIS. LITERATURE ALSO SHOWS THAT SURGICAL APPROACH AND IMPLANT POSITIONING CAN IMPACT THE WEAR PERFORMANCE OF TOTAL HIP ARTHROPLASTY. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES/RADIOGRAPHS WERE NOT PROVIDED. E1, 2, 3, 4. INITIAL REPORTER CHANGED F6 & 8. THIS IS A MANUFACTURERS REPORT, NO FACILITY INFORMATION APPLICABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, D8, H6 - HEALTH EFFECT - CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION AND H11. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM SIGNIFICANT EDGE LOADING OF THE FEMORAL HEAD ON THE ACETABULAR LINER AND COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED; 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). 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 PATIENT HAD AN INITIAL RIGHT THA ON OR ABOUT (B)(6) 2014. ON (B)(6) 2022, THE PATIENT WAS REVISED DUE TO POLYETHYLENE FAILURE. X-RAYS SHOWED ECCENTRICITY OF THE FEMORAL HEAD WITHIN THE ACETABULAR COMPONENT. MOREOVER, PROGRESSION OF THE THINNING OVER SEVERAL X-RAYS SUGGESTED POLYETHYLENE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246978 NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 130-36-52 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10