BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP COMPONENTS

    MDR report key: 21698410 · Received March 26, 2025

    Report

    Report Number
    1038671-2025-01663
    Event Type
    Injury
    Date Received
    March 26, 2025
    Report Date
    April 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 101-05-20 - 3.2MM DRILL BIT 20MM 1PK: 5381162; 136-36-52 - NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS: 3873814; 170-36-93 - BIOLOX DELTA FEM HEAD 36MM OD, -3.5MM: 5569548; 180-65-20 - ALTEON 6.5MM SCREW, 20MM: S003719; 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2: 5568168; 190-31-04 - ALT HA S CLR EXT SZ 4: 4896699. H3: THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    IT WAS REPORTED THAT THIS PATIENT'S LEFT HIP WILL BE REVISED IN THE NEAR FUTURE. PATIENT INDICATED THE IMPLANT WAS GETTING LOST AND GOT DEPLETED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694824 UNKNOWN HIP COMPONENTS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| O SEE H11