BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 OSSEOTI 3 HOLE SHELL 50MM D

    MDR report key: 7596631 · Received June 13, 2018

    Report

    Report Number
    0001825034-2018-03796
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Report Date
    July 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: ITEM# 010000848 G7 NEUTRAL E1 LINER 32MM D LOT# 6152298. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING TOTAL HIP ARTHROPLASTY THE LINER WOULD NOT SEAT IN THE CUP. SURGERY WAS COMPLETED WITH BACK UP CUP. NO ADVERSE EVENT NOTED TO PATIENT. ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438621 G7 OSSEOTI 3 HOLE SHELL 50MM D PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6178290

    Patients

    Seq Age Sex Outcome Treatment
    1