BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS

    MDR report key: 19154532 · Received April 22, 2024

    Report

    Report Number
    1038671-2024-00928
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    October 2, 2023
    Report Date
    February 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862023315
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: N/A 32135-38H - FLEX DRILL M3.2X38 HD LENKBAR. 5632905 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2. 5751845 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2. 6013023 170-32-03 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +3.5MM. 6165213 188-00-08 - WEDGE PLASMA S/O SZ 8. 6192150 170-32-00 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM. 6247573 188-01-07 - WEDGE PLASMA X/O SZ 7. S031512 180-65-25 - ALTEON 6.5MM SCREW, 25MM. S035582 180-65-25 - ALTEON 6.5MM SCREW, 25MM. H7: RECALL NUMBER: Z-1729-2022. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT. THE CAUSE OF PROSTHESIS WEAR IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS IS A COMBINATION OF THE 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 AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2020 AND THEN WAS REVISED APPROXIMATELY 3 YEARS 8 MONTHS LATER ON (B)(6) 2023. PATIENT WAS RECOMMENDED ELECTIVE REVISION SURGERY DUE TO IMPLANT RECALL FOR PROSTHESIS WEAR. DURING THE REMOVAL OF THE ORIGINAL IMPLANT, IT WAS FOUND THAT THE ACETABULAR LINER HAD GROSSLY MILD WEAR. THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION; NO COMPLICATIONS AND PROCEDURE WAS TOLERATED WELL. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE IS NO OTHER INFORMATION PROVIDED/AVAILABLE. THE MOSTLY 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. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036021 NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862023315

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention