BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS

    MDR report key: 19112162 · Received April 15, 2024

    Report

    Report Number
    1038671-2024-00851
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 19, 2024
    Report Date
    February 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024336
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 4209539 170-36-07 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM. S036685 180-65-20 - ALTEON 6.5MM SCREW, 20MM. S041638 180-65-20 - ALTEON 6.5MM SCREW, 20MM. 6169618 186-01-56 - INTEGRIP CC, CLUSTER 56MM,G3. 6295755 190-30-08 - ALT HA S CLR STD SZ 8.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-02483. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6. THE FOLLOWING SECTIONS WERE CORRECTED: B1. B2. G2. H6. [LIST ONLY MDR SECTION CODES UPDATED/CORRECTED IN ALPHABETICAL ORDER]. [MLUC: REMOVE ALL NUMBERS] IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Description of Event or Problem · 0

    EXPERIENCE REPORT - USA PATIENT ID: (B)(6) AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2020. THE PATIENT HAD A REVISION OF THE CUP AND GXL LINER TO COMPETITOR DEVICES ON (B)(6) 2024; REASON NOT REPORTED. THE STEM WAS RETAINED AND A NEW HEAD BALL WAS IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683135 NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862024336

    Patients

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