BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 7793192 · Received August 17, 2018

    Report

    Report Number
    0001825034-2018-08232
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    July 19, 2018
    Report Date
    December 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08229-1, 0001825034-2018-08230-1, 0001825034-2018-08231-1, 0001825034-2018-08232-1. 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

    (B)(4). REPORT SOURCE, FOREIGN - (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08229, 0001825034-2018-08230, 0001825034-2018-08231, 0001825034-2018-08232.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT HIP REVISION PROCEDURE DUE TO UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633343 UNKNOWN STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN ACETABULAR SHELL, CATALOGUE# NI, LOT# NI| UNKNOWN HEAD CATALOGUE# NI, LOT# NI| UNKNOWN LINER CATALOGUE# NI, LOT# NI| UNKNOWN ACETABULAR SHELL, CATALOGUE# NI, LOT# NI| UNKNOWN HEAD CATALOGUE# NI, LOT# NI| UNKNOWN LINER CATALOGUE# NI, LOT# NI