BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION CFS CEM, STD, SIZE 12

    MDR report key: 12089222 · Received June 29, 2021

    Report

    Report Number
    1038671-2021-00319
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    May 19, 2021
    Report Date
    October 20, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862036278
    PMA / PMN Number
    K090764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G7, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) AS REPORTED BY THE EXACTECH HIP REPLACEMENT STUDY, APPROXIMATELY TWENTY-THREE DAYS POST LTHA, THE 83 Y/O FEMALE PATIENT WAS HOSPITALIZED DUE TO DETECTION OF A COLLECTION OF FLUID COMPATIBLE WITH AN ABSCESS IN MRI TWO WEEKS AFTER SURGERY. RESOLVED WITH ANTIBIOTIC TREATMENT. PATIENT DISCHARGED AFTER 2 WEEKS. THE CLINICAL STUDY REPORTED THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. DEVICES REMAIN IMPLANTED. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT ANTIBIOTIC TREATMENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: FEMORAL HEAD (CAT# 142-28-93). FEMORAL HEAD (CAT# 150-042). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6) STUDY, APPROXIMATELY TWENTY-THREE DAYS POST LTHA, THE (B)(6) Y/O FEMALE PATIENT WAS HOSPITALIZED DUE TO DETECTION OF A COLLECTION OF FLUID COMPATIBLE WITH AN ABSCESS IN MRI TWO WEEKS AFTER SURGERY. RESOLVED WITH ANTIBIOTIC TREATMENT. PATIENT DISCHARGED AFTER 2 WEEKS. THE CLINICAL STUDY REPORTED THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985109 NOVATION CFS CEM, STD, SIZE 12 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NOVATION CFS CEM, STD, SIZE 12 UNK 10885862036278

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention