BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -6MM NECK

    MDR report key: 4196058 · Received October 23, 2014

    Report

    Report Number
    0001825034-2014-08299
    Event Type
    Injury
    Date Received
    October 23, 2014
    Report Date
    January 21, 2016
    Manufacturer
    BIOMET FRANCE SARL
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 1 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08299 & 08696 / 08695). REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08299 AND 08695 / 08697).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT EXPERIENCED A DEEP INFECTION LESS THAN SIX WEEKS AFTER THE INITIAL PROCEDURE. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 WHERE THE WOUND WAS FLUSHED AND AN ANTIBIOTIC IV WAS STARTED. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT EXPERIENCED A DEEP INFECTION LESS THAN SIX WEEKS AFTER THE INITIAL PROCEDURE. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 WHERE THE WOUND WAS FLUSHED AND AN ANTIBIOTIC IV WAS STARTED. PATIENT REMAINED IN THE HOSPITAL UNTIL (B)(6) 2014 AND STILL HAS BI-WEEKLY CHECKS AT THE HOSPITAL WITH LAB. THE REASON FOR INFECTION IS UNKNOWN, BUT IS NOT BELIEVED TO BE RELATED TO THE IMPLANTS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675850 32MM MOD HEAD COCR -6MM NECK PROSTHESIS, HIP JDI BIOMET FRANCE SARL N/A 00J3252811

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R