BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19341454 · Received May 17, 2024

    Report

    Report Number
    1038671-2024-01308
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    December 21, 2020
    Report Date
    November 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022233
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CORRECTED D10: CONCOMITANT DEVICES. 2661124 186-01-56 - INTEGRIP CC, CLUSTER 56MM,G3. 3001768 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM. 3580319 164-12-10 - NOVATION ELEMENT RO X/O SZ 10. G4: CORRECTED THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN HHE2020-09-11-02. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICES ARE UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D1: UPDATED. D4: UPDATED. D10 CONCOMITANT DEVICES: (B)(6) 186-01-56 - INTEGRIP CC, CLUSTER 56MM,G3. (B)(6) 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM. (B)(6) 130-36-53 - NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS. (B)(6) 164-12-10 - NOVATION ELEMENT RO X/O SZ 10. H4: UPDATED. H6: CORRECTED THE FOLLOWING: TYPE OF INVESTIGATION. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION IS DUE TO PROSTHESIS WEAR A COMBINATION OF THE RISK FACTORS SPECIFIED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A REVISED RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A 2ND REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970938 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862022233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11.| SEE H11.