BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 36MM F

    MDR report key: 16094428 · Received January 4, 2023

    Report

    Report Number
    0001825034-2022-02869
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 9, 2022
    Report Date
    February 28, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527119
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. ONE G7 HI-WALL E1 LINER 36MM F ITEM# 010000936 LOT# 6983678 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE WAS AN INDENTATION ON THE INSIDE LIP OF THE LINER ALONG WITH TWO ON THE OUTSIDE RADIUS. THERE WAS NO VISIBLE DAMAGE TO THE LOCKING FEATURE OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). ITEM NUMBER: 010000665. ITEM NAME: G7 PPS LTD ACET SHELL 56F. LOT: 7084958. ITEM NUMBER: 110003623. ITEM NAME: BIOLOX DELTA CER LNR 36MMF. LOT: 3111529. FOREIGN: CHINA. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE DOCTOR PLACED THE G7 CUP PROPERLY ACCORDING TO THE SURGICAL TECHNIQUE OF OUR PRODUCT, AND THEN WHEN THE VITAMIN E1 LINER WAS INSTALLED ACCORDING TO THE SURGICAL TECHNIQUE OF OUR PRODUCT, IT DID NOT LOCK PROPERLY. NO DELAY REPORTED. ONLY THE LINER NEEDED TO BE REPLACED. NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472000 G7 HI-WALL E1 LINER 36MM F PROSTHETIC, HIP PBI ZIMMER BIOMET, INC. N/A 6983678 00880304527119

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male