BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19153988 · Received April 22, 2024

    Report

    Report Number
    1038671-2024-00924
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 27, 2024
    Report Date
    June 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862549228
    PMA / PMN Number
    K182502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 6826277 01-030-40-0736 - ALT XLE LNR NTRL G7 36. 7242930 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM. 6388935 190-21-08 - ALT HA S NOCLR EXT SZ 8.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REPORTED SURGICAL INTERVENTION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR SURGICAL PROCEDURE. ADDITIONALLY, INFECTION IS A KNOWN SURGICAL RISK, AS OUTLINED IN THE IFU. D1: CORRECTED. D4/D6: DEVICE, SERIAL #, UDI #, EXPIRATION, OCCURRENCE AND EXPLANT DATES UNKNOWN. G3: MANUFACTURED DATES UNKNOWN. G4: PMA 510K CANNOT BE DETERMINED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, THE 48 YEAR OLD MALE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2022. THE PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO AN INFECTED TOTAL HIP. THE IMPLANTS WERE REMOVED AND A SPACER 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. X-RAYS PROVIDED. PRODUCT NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843727 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862549228

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male SEE H10