BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 DUAL MOBILITY LINER

    MDR report key: 7269251 · Received February 14, 2018

    Report

    Report Number
    0001825034-2018-00913
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    February 13, 2017
    Report Date
    February 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK150522
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010271 G7 OSSEOTI MULTIHOLE 66MM I R3714016A, EP-200160 ACT ARTIC E1 HIP BRG 28X54MM 950150, UNK ZIMMER HEAD, UNK STEM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PHOTOGRAPH OF THE EXPLANTED HEAD AND ACTIVE ARTICULATION BEARING IS PROVIDED. NO NOTABLE DAMAGES ARE SEEN ON THE PHOTOGRAPH. NO FURTHER EVALUATION POSSIBLE USING THE PHOTOGRAPH PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT HIP ARTHROPLASTY. SUBSEQUENTLY, DURING THE PROCEDURE, THE LINER WAS DIFFICULT TO REMOVE FROM THE ACETABULAR SHELL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112478 G7 DUAL MOBILITY LINER HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 879310

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR