BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 40MM F

    MDR report key: 9156009 · Received October 4, 2019

    Report

    Report Number
    0001825034-2019-04453
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    September 15, 2019
    Report Date
    December 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 650-1058 CER BIOLOXD OPTION HD 40MM LOT# 2982814, ITEM# 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 LOT# 2959047, ITEM# UNKNOWN UNKNOWN STEM LOT# UNKNOWN, ITEM# UNKNOWN UNKNOWN SHELL LOT# UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT REVISION DUE TO INFECTION APPROXIMATELY 1 MONTH AFTER INITIAL IMPLANTATION IN WHICH SURGEON IRRIGATED/DEBRIDED FOR POSSIBLE INFECTION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950165 G7 HI-WALL E1 LINER 40MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6544646

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ..