BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 40MM F

    MDR report key: 12908078 · Received December 1, 2021

    Report

    Report Number
    0001825034-2021-03205
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 2, 2021
    Report Date
    December 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: CATALOG#: 650-1064 ITEM NAME: CER OPTION TYPE 1 TPR SLEVE -6 LOT#: 2953792. CATALOG#: 650-1058 ITEM NAME: CER BIOLOXD OPTION HD 40MM LOT#: 2957975. 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.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR NO PHOTOGRAPHS WERE PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO COMPATIBILITY ISSUES WERE SEEN. NO MEDICAL RECORDS WERE PROVIDED. ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR REPLACED A REGULAR LINER FOR A FREEDOM CONSTRAINED FOR DISLOCATING. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811130 G7 NEUTRAL E1 LINER 40MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6438614

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R