BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS

    MDR report key: 19154867 · Received April 22, 2024

    Report

    Report Number
    1038671-2024-00930
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    October 2, 2023
    Report Date
    August 2, 2024
    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: (B)(6) - FLEX DRILL M3.2X38 HD LENKBAR. (B)(6) 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2. (B)(6) 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2. (B)(6) 170-32-03 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +3.5MM. (B)(6) 188-00-08 - WEDGE PLASMA S/O SZ 8. (B)(6) 170-32-00 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM. (B)(6) 188-01-07 - WEDGE PLASMA X/O SZ. (B)(6) 180-65-25 - ALTEON 6.5MM SCREW, 25MM. (B)(6) 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 EVENT WAS DETERMINED TO BE A DUPLICATE OF CASE(B)(4)/ 1038671-2024-00928. PLEASE REFERENCE 1038671-2024-00928 FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT 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, GROSS FINDINGS OF THE RIGHT HIP JOINT INCLUDED MODERATE WEARING OF THE ARTICULAR BEARING. THERE WAS MILD LYSIS OF THE BONE AROUND THE RIM OF THE ACETABULUM AROUND THE PROXIMAL ASPECT OF THE FEMUR AFTER DISSECTION OF ASSOCIATED SOFT TISSUE WITH A RONGEUR AND A CURETTE. 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
    1432162 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 SEE H10