BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET STEM

    MDR report key: 11208108 · Received January 21, 2021

    Report

    Report Number
    0001825034-2021-00120
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    December 23, 2020
    Report Date
    April 26, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    CMP (B)(4). UNKNOWN DAY IN 2016 BIOMET CERAMIC HEAD CAT#UNK LOT#1051754 BIOMET CERAMIC SLEEVE CAT#UNK LOT#UNK THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO BEING UNAVAILABLE BY HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY 4 YEARS LATER DUE TO STEM SUBSIDENCE. THE STEM AND MODULAR HEAD COMPONENTS WERE REMOVED AND REPLACED. THE REVISING DOCTOR NOTED THAT THE ORIGINAL DOCTOR UNDERSIZED THE STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106631 UNKNOWN BIOMET STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 3755957

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.| SEE H10 NARRATIVE