BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SHELL

    MDR report key: 7603602 · Received June 14, 2018

    Report

    Report Number
    0001825034-2018-04021
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 18, 2018
    Report Date
    January 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE RETURNED PRODUCT WAS EVALUATED AGAINST THE COMPLAINT. THE LINER AND 3HOLE SHELL WERE ASSEMBLED UPON RECEIPT. THE FLUSH PROFILE OF THE LINER AND 3 HOLE ASSEMBLY IMPLIES THAT THE LINER IS FULLY SEATED. THE LINER COULD NOT BE REMOVED BY HAND. NO MOTION OF ANY KIND WAS FELT OR OBSERVED DURING THE ATTEMPTS TO REMOVE THE LINER FROM THE SHELL. INDENTATIONS AND SCRATCHES WERE FOUND ON THE LINER'S RIM. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. MEDICAL DEVICES: ITEM NUMBER: 110010262, ITEM NAME: G7 MULTIHOLE SHELL, LOT #: 6243619, ITEM NUMBER: 010000847, ITEM NAME: G7 LINER, LOT #: 6108986, ITEM NUMBER: 51-149080, ITEM NAME: TAPERLOC STEM, LOT #: 3892043, ITEM NUMBER: 010000999, ITEM NAME: G7 SCREW, LOT #: 6025553. FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04022, 0001825034 - 2018 - 04023, 0001825034 - 2018 - 04024. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER WOULD NOT SEAT WITH THE ACETABULAR SHELL. SHELL AND LINER WERE REMOVED AND REPLACED. SURGERY WAS DELAYED BY APPROXIMATELY 1-2 HOURS. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446246 G7 SHELL PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6250495

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention