BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD +9MM

    MDR report key: 8130895 · Received December 4, 2018

    Report

    Report Number
    0001825034-2018-10940
    Event Type
    Injury
    Date Received
    December 4, 2018
    Report Date
    June 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). MEDICAL DEVICES: ITEM# 010000781 G7 10 DEG ARCOMXL LINER 36MM G LOT# 3905091; ITEM# 010000819 G7 HI-WALL ARCOMXL LNR 36MM F LOT# 6014211. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 10941.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED MULTIPLE DISLOCATIONS AFTER REVISION PROCEDURE TO PUT THE HIP BACK IN PLACE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971096 36MM COCR MOD HD +9MM PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A 358810

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R