BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 40MM I

    MDR report key: 14878589 · Received June 30, 2022

    Report

    Report Number
    0001825034-2022-01513
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 8, 2022
    Report Date
    July 29, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527195
    PMA / PMN Number
    K121874
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000670- G7 PPS LTD ACET SHELL 66I- 3822395. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE G7 HI-WALL E1 LINER 40MM I ITEM# 010000945 LOT# 6181184 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE LOCKING FEATURE OF THE DEVICE WAS DAMAGED PRIOR TO RETURN. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED THEY WERE NOT ABLE TO SEAT THE LINER FULLY INTO THE CUP. A SECOND LINER WAS OPEN AND ABLE TO SEAT THE CUP SUCCESSFULLY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481492 G7 HI-WALL E1 LINER 40MM I PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6181184 00880304527195

    Patients

    Seq Age Sex Outcome Treatment
    1 Male SEE H10 NARRATIVE.