BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 CURVED INSERTER THD SHAFT

    MDR report key: 18746543 · Received February 21, 2024

    Report

    Report Number
    0001825034-2024-00427
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 26, 2024
    Report Date
    April 17, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00887868462528
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110003454 ITEM NAME G7 CURVED INSERTER THD SHAFT LOT # 083625 UNKNOWN G7 CUP G2: FOREIGN: CANADA MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034 - 2024 - 00428 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. H3 OTHER TEXT : DEVICE IN PROCESS TO RETURN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED NO THREAD DAMAGE CAN BE SEEN. INSERTERS ARE COVERED IN BIO-DEBRIS AND HAVE SIGNS OF USE. UNABLE TO CONFIRM COMPLAINT AS NO PRODUCT WAS RETURNED OR MEDICAL RECORDS WERE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE SURGEON AND NURSE TRIED TO ATTACH THE G7 CUP TO THE INSERTER, THE THREADS WOULDN'T SCREW INTO THE CUP. ANOTHER INSERTER WAS ATTEMPTED WITH THE SAME ISSUE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE AFTER SEVERAL ATTEMPTS BUT FOUND IT WAS MORE DIFFICULT THAN USUAL. THE THREADS WERE NOT VISIBILY DAMAGED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67329 G7 CURVED INSERTER THD SHAFT INSTRUMENT, HIP PBI ZIMMER BIOMET, INC. N/A 083625 00887868462528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose PLEASE SEE H10