BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

    MDR report key: 20553359 · Received October 28, 2024

    Report

    Report Number
    1038671-2024-04156
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 22, 2024
    Report Date
    July 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022233
    PMA / PMN Number
    K070479
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 150-07-17 - MODULAR STRAIGHT STEM 13MM X 200MM 1486245, 150-25-01 - MODULAR SMALL META 25MM 1556745, 122-65-40 - 6.5MM ACETABULAR BONE SCREW 40MM 1654171, 122-65-25 - 6.5MM ACETABULAR BONE SCREW 25MM 1654281, 158-02-01 - 12/14 LPB M-SERIES NECK HI OFFSET +0 1827043, 180-01-58 - NV CROWN CUP CLSTR HOLE 58MM GROUP 3 1832781, 148-36-00 - 12/14 ZIRCONIA HEAD 36MM REP BY 170-36-00 1860242.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, D4, D6B, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G. THE REPORTED PROSTHESIS WEAR COULD BE CONFIRMED FROM THE PROVIDED RADIOGRAPH. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION REPORTED IS 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) AND BEING IMPLANTED FOR MORE THAN 10 YEARS. HOWEVER, THE POTENTIAL ROOT CAUSE 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

    EMAIL TO COMPLAINTS USA. HIP REVISION. PATIENT ID: (B)(6). IT WAS REPORTED THAT THIS PATIENT'S HIP WILL BE REVISED. AT THIS TIME PLAN IS FOR HEAD AND LINER EXCHANGE WITH POLY WEAR. ACETABULAR CYST PRESENT, NO FURTHER INFORMATION AT THIS TIME. HI DR. (B)(6), I HOPE YOU ARE WELL. I AM REACHING OUT REGARDING AN UPCOMING HIP REVISION WITH EXACTECH IMPLANTS SCHEDULED ON OCT 22. I AM YOUR REP FOR THE CASE. CAN YOU PLEASE PROVIDE ME PATIENT NAME AND DOB SO I CAN ACQUIRE IMPLANT... GOOD MORNING, PATIENT IN QUESTION IS (B)(6), (B)(6)1963. AT THIS TIME PLAN IS FOR HEAD AND LINER EXCHANGE WITH POLY WEAR. ACETABULAR CYST PRESENT SO CHANCE WE HAVE TO REVISE ACETABULAR COMPONENT AND WILL PLAN ON REMOVING ACETABULAR SCREWS AT THE VERY LEAST. APPRECIATE YOUR ASSISTANCE WITH THIS CASE. SINCERELY, (B)(6). 130-36-53 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS 1814297. UDI NUMBER (B)(4). 510(K) NUMBER K070479. PRODUCT CODE JDI, LPH, LWJ, LZO, MEH. RECALL NUMBER Z-1729-2022. CONCOMITANTS: 150-07-17 - MODULAR STRAIGHT STEM 13MM X 200MM 1486245, 150-25-01 - MODULAR SMALL META 25MM 1556745, 122-65-40 - 6.5MM ACETABULAR BONE SCREW 40MM 1654171, 122-65-25 - 6.5MM ACETABULAR BONE SCREW 25MM 1654281, 158-02-01 - 12/14 LPB M-SERIES NECK HI OFFSET +0 1827043, 180-01-58 - NV CROWN CUP CLSTR HOLE 58MM GROUP 3 1832781, 148-36-00 - 12/14 ZIRCONIA HEAD 36MM REP BY 170-36-00 1860242. NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321869 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022233

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention