BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 40MM ID, GROUP 4 CUPS

    MDR report key: 19650260 · Received July 1, 2024

    Report

    Report Number
    1038671-2024-02239
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 22, 2023
    Report Date
    November 14, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207050
    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

    CONCOMITANT DEVICES: (4868527) 186-01-60 - INTEGRIP CC, CLUSTER 60MM, G4 (4947515) 170-40-03 - BIOLOX DELTA FEMORAL HEAD 40MM 0D, +3.5MM (5039491) 180-65-25 - ALTEON 6.5MM SCREW, 25MM (5039658) 180-65-15 - ALTEON 6.5MM SCREW, 15MM (5211939) 101-45-30 - 4.5MM DRILL BIT 30MM (5237593) 180-65-25 - ALTEON 6.5MM SCREW, 25MM (5253823) 188-01-07 - WEDGE PLASMA X/O SZ 7. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-1732-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS THE CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: TYPE OF INVESTIGATION MANUFACTURER NARRATIVE UPDATED: THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR IS 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). ADDITIONALLY, THE SEQUENCE OF EVENTS AS RELATED TO THE REPORTED WEAR CANNOT BE CONFIRMED AND THE CONTRIBUTIONS OF EACH TO THE REPORTED EVENT CANNOT BE DETERMINED. 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 62 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A 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
    973447 NV GXL LINER LIPPED 40MM ID, GROUP 4 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862207050

    Patients

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