BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 DUAL MOBILITY LINER 46MM G

    MDR report key: 15083403 · Received July 22, 2022

    Report

    Report Number
    0001825034-2022-01654
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 27, 2022
    Report Date
    September 14, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304703537
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CATALOG NUMBER: 110010267 LOT NUMBER:65375054 BRAND NAME: G7 MULTIHOLE SHELL CATALOG NUMBER: 110024465 LOT NUMBER:111870 BRAND NAME: G7 DUAL MOBILITY LINER 46MM G MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001825034-2022-01655 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 DUAL MOBILITY LINER 46MM G ITEM# 110024465 LOT# 111870 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE LINER HAD SCUFFING ON THE OD AND THERE WAS GOUGING ON THE INSIDE RADIUS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE LINER ALIGNMENT RING BECAME LODGED IN BETWEEN THE SHELL AND THE LINER AFTER IMPACTION. THE LINER AND BROKEN RING WERE REMOVED AND A NEW LINER WAS IMPLANTED WITHOUT ANY FURTHER COMPLICATIONS. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    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
    611223 G7 DUAL MOBILITY LINER 46MM G PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 111870 00880304703537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10 NARRATIVE