BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 54F

    MDR report key: 8063591 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10513
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 12, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000999 ¿ G7 SCREW ¿ 6223765, 51-108040 ¿ TAPERLOC STEM ¿ 6156034, 11-363660 ¿ COCR MODULAR HEAD ¿ 480720, 010000741 ¿ G7 LINER - 6320853. REPORT SOURCE (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE SURGEON DID NOT APPROVE OF THE RETURN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10512.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUP PLACEMENT WAS NOT IDEAL AND A SCREW WAS PLACED IN A POTENTIALLY DANGEROUS ZONE APPROXIMATELY 1 WEEK POST HIP PROCEDURE. THE SURGEON THEN OPTED TO REMOVE ALL IMPLANTS TO FACILITATE A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905023 G7 PPS LTD ACET SHELL 54F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6369499

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R