BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 17286662 · Received July 10, 2023

    Report

    Report Number
    1038671-2023-01591
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    June 13, 2023
    Report Date
    April 16, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022233
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    10: CONCOMITANTS: 101-45-40 - 4.5MM DRILL BIT 40MM 4016469. 188-01-11 - WEDGE PLASMA X/O SZ 11 4088217. 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM 4119805. 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3 4133299. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    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 CANNOT BE NOT CONFIRMED WITH THE INFORMATION PROVIDED; DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN 82 YO MALE PATIENT, INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS OF PAIN AND DISSATISFACTION WITH THEIR RIGHT PRIMARY EXACTECH HIP. THE PATIENT HAD A RECALLED GXL POLY LINER AND WAS BOOKED FOR REVISION SURGERY. THEY UNDERWENT A HIP POLY LINER AND HEAD SWAP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES ARE RETURNING. THE IMPLANTS WERE REQUIRED TO BE SENT TO THE LAB AT THE HOSPITAL AND THEN LEGAL. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233881 NOVATION PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS UNK 10885862022233

    Patients

    Seq Age Sex Outcome Treatment
    1