BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

    MDR report key: 19777443 · Received July 18, 2024

    Report

    Report Number
    1038671-2024-02448
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    April 24, 2011
    Report Date
    July 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES 0796038 132-28-28 - ACUMATCH GXL 15DEG LINER 28MM SZ H; 829218 116-01-04 - ACUMATCH C-SERIES 12/14 SZ 4; 904883 120-65-25 - BONE SCREW 6.5MM DIA X 25MM LONG; 789828 120-65-45 - BONE SCREW 6.5MM DIA X 45MM LONG; 378274 124-01-56 - ACUMATCH CLUSTER CUP POROUS BEAD W/HA 56MM; 4661203 13A2101 - CEMEX SYSTEM FAST GENTA 70G; 802570 142-28-00 - COCR FEM HEAD 28MM +0 OFFSET 12/14; 6060114 620-00-01 - ACCELERATE PRP KIT 2 SPIN; F92F KIT-01 - CEMEX PREP KIT; 756863 PC-17 - STEM CENTRALIZER 17MM. 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 A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2011 APPROXIMATELY 4 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION OR MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033093 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11