BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUPORT SIDE-DEL 11GA X 120MM

    MDR report key: 13088312 · Received December 27, 2021

    Report

    Report Number
    3008812173-2021-00007
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    December 1, 2021
    Report Date
    January 21, 2022
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    MQV
    UDI-DI
    00889024205116
    PMA / PMN Number
    K190814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H6 (HEALTH EFFECT - IMPACT CODE).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THE SUBCHONDROPLASTY SIDE DELIVERY CANNULA BROKE INSIDE A PATIENT WHILST DRILLING BY THE USER. THIS RESULTED IN A 20 MINUTE DELAY IN SURGERY WHILST THE SURGEON REMOVED THE BROKEN TIP FROM THE PATIENTS BONE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985509 ACCUPORT SIDE-DEL 11GA X 120MM FILLER, BONE VOID MQV ZIMMER KNEE CREATIONS, INC. N/A 47972 00889024205116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown