BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS

    MDR report key: 18813258 · Received February 29, 2024

    Report

    Report Number
    1038671-2024-00364
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    January 30, 2024
    Report Date
    December 17, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207043
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 5083867 101-05-30 - 3.2MM DRILL BIT30MM 1PK. 4300556 164-12-12 - NOVATION ELEMENT RO X/O SZ 12. 4911940 170-40-03 - BIOLOX DELTA FEMORAL HEAD 40MM 0D, +3.5MM. 4559372 180-65-40 - ALTEON 6.5MM SCREW, 40MM. 5112913 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D1, G3, H6. THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, G. BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS AS SPECIFIED IN THE HHE: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN 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. 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 THAT A 73 YO FEMALE PATIENT, INITIAL RIGHT HIP IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON WITH A RECALLED HIP LINER AND WAS SCHEDULED FOR A REVISION. THE ACETABULAR POLY LINER AND THE FEMORAL HEAD WERE REPLACED TO A BIOLOX DELTA ADAPTER 16/18-12/14; +3.5MM SN: (B)(6), BIOLOX DELTA OPTION FEMORAL HEAD 40MM OD SN: (B)(6), AND A NV EHXL LIPPED LNR G3 40MM SN: (B)(6). THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THEY WERE SENT TO THE HOSPITAL¿S LAB AND LEGAL DEPT. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307070 NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS UNK 10885862207043

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention SEE H10.