BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 LACTOSORB SYSTEM CURVED PLATE - 6 HOLE

    MDR report key: 8616820 · Received May 16, 2019

    Report

    Report Number
    0001032347-2019-00283
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    January 15, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036055677
    PMA / PMN Number
    K971870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. BECAUSE IT WAS REPORTED THAT A REVISION SURGERY OCCURRED, THE COMPLAINT IS CONFIRMED. THE DHR FOR THE PLATE WAS REVIEWED, NO NON-CONFORMANCES WERE FOUND. FOR THIS PART (915-2427) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE), THERE IS A COMPLAINT RATE OF 0.213% REGARDING AN INFECTION WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED, HOWEVER, IT WAS REPORTED THAT IT WAS BELIEVED THE LACTOSORB PRODUCT DID NOTCAUSE/CONTRIBUTE TO THE INFECTION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - UNKNOWN BIOMET MICROFIXATION LACTOSORB SCREWS CATALOG #: NI, LOT #: NI. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION OCCURRED DUE TO THE PATIENT CONTRACTING AN INFECTIOUS DISEASE. APPROXIMATELY FOUR MONTHS AGO, THE SURGEON DETECTED THE PATIENT HAD (B)(6), STREPTOCOCCUS INTERMEDIUS AND PEPTOSTREPTOCOCCUS MICROS. THE PATIENT WAS TREATED WITH ANTIBIOTICS BUT WAS REVISED APPROXIMATELY THREE WEEKS AGO DUE TO INSUFFICIENT RECOVERY. CULTURES HAVE BEEN TAKEN BUT THE RESULTS HAVE NOT BEEN OBTAINED YET. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409059 1.5 LACTOSORB SYSTEM CURVED PLATE - 6 HOLE PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 318030 00841036055677

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R