BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17287366 · Received July 10, 2023

    Report

    Report Number
    1038671-2023-01592
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    December 8, 2022
    Report Date
    April 15, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 3955650 164-13-12 - NOVATION ELEMENT RO S/O COL SZ 12. 3948485 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM. 3903016 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION RESULTS - THE MOST 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 MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. HOWEVER, THIS IS NOT CONFIRMED, THE DEVICES WERE NOT RETURNED. THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, G2, H6: CLINICAL CODE COMPONENT CODE, TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS. 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 VIA LEGAL DOCUMENTATION A 62 Y/O FEMALE PATIENT HAD A LEFT HIP REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT HIP REVISION ON (B)(6) 2022 DUE TO PAIN. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2022. POST PROCEDURE DIAGNOSIS: FAILED LEFT TOTAL HIP ARTHROPLASTY. FINDINGS: WEAR OF WEIGHTBEARING PORTION OF POLYETHYLENE LINER, INFLAMED SYNOVIUM, STABLE FEMORAL AND ACETABULAR COMPONENTS. NO COMPLICATIONS DURING THE PROCEDURE, THE PATIENT WAS POSITIONED SUPINE EMERGED FROM ANESTHESIA IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478754 NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R SEE H10.