BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

    MDR report key: 19983633 · Received August 14, 2024

    Report

    Report Number
    1038671-2024-02838
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    September 1, 2023
    Report Date
    February 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207029
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 4770146, 132-32-51 - NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS. 5774421, 188-00-06 - WEDGE PLASMA S/O SZ 6. 5865397, 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1. 6039561, 142-32-93 - COCR FEM HEAD 32MM -3.5 OFFSET 12/14. S018017, 180-65-20 - ALTEON 6.5MM SCREW, 20MM. N/A, 32135-38H - FLEX DRILL M 3.2X38 HD LENKBAR. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING IN BODY AND MIND; ADDITIONAL SURGERIES, PAIN, LOSS OF A NORMAL LIFE, AND LOSS OF INCOME; MEDICAL CARE IN THE PAST AND FUTURE; UNABLE TO ATTEND TO HER NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME; SUBSTANTIAL LOSS OF INCOME. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517560 NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862207029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.