BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR STEM

    MDR report key: 10648632 · Received October 8, 2020

    Report

    Report Number
    0009613350-2020-00473
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED OCTOBER 7TH, 2020 PROVIDED IDENTIFICATION NUMBERS (REF AND LOT) OF THE STEM WHICH INDICATED THAT THE AVENIR COMPLETE STEM ORIGINALLY REPORTED BY ZIMMER SWITZERLAND MANUFACTURING GMBH, IS DESIGN OWNED BY ZIMMER BIOMET, INC. (WARSAW; USA) AND HAS THEREFORE BEEN REPORTED IN A DIFFERENT COMPLAINT (B)(4)/ MDR REPORT NUMBER 0001822565-2020-03502. ZIMMER SWITZERLAND MANUFACTURING WILL INVALIDATE THIS COMPLAINT (B)(4).

    Description of Event or Problem · 0

    IDENTIFICATION NUMBERS RECEIVED (REF AND LOT). AVENIR COMPLETE STEM ORIGINALLY REPORTED BY ZIMMER SWITZERLAND MANUFACTURING, IS DESIGN OWNED BY ZIMMER BIOMET, INC. (WARSAW; USA). NEW MDR REPORT NUMBER: 0001822565-2020-03502.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN TRIAL HEAD; CATALOG#: UNKNOWN; LOT#: UNKNOWN. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    DURING INITIAL SURGERY ON AN UNKNOWN SIDE THE TRIAL HEAD GOT STUCK IN THE AVENIR STEM. THE TRIAL HEAD COULDN'T BE DISENGAGED FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118315 AVENIR STEM AVENIR STEM KWY ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10 NARRATIVE.