BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS

    MDR report key: 19422958 · Received May 30, 2024

    Report

    Report Number
    1038671-2024-01571
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    September 25, 2023
    Report Date
    November 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    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

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE MANUFACTURER NARRATIVE UPDATED: 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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 32135-38H - FLEX DRILL M 3.2X38 HD LENKBAR, 6202783 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2, 6214501 142-32-03 - COCR FEM HEAD 32MM +3.5 OFFSET 12/14, 6252397 188-00-09 - WEDGE PLASMA S/O SZ 9, S042465 180-65-25 - ALTEON 6.5MM SCREW, 25MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL [ENTER RECALL #]; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 43 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR POLY FAILURE WITH EXCESSIVE WEAR, POLY DEBRIS, PAIN, OSTEOLYSIS, TISSUE DAMAGE. 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
    1424300 NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10