BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BONEMASTER LTD ACET SHL 52E

    MDR report key: 7512597 · Received May 14, 2018

    Report

    Report Number
    0001825034-2018-03323
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    April 5, 2018
    Report Date
    November 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES WOULD CONTRIBUTE TO REPORTED EVENT. 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. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN- (B)(6). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K121874 (PRODUCT CODE PBI). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE RIGHT PRIMARY HIP PROCEDURE, THE SCREW HOLE PLUG COULD NOT BE REMOVED FROM THE 52 MM CUP, IN ORDER TO SECURE TO THE CUP WITH A SCREW. THE SURGEON HAD TO REAM UP THE SIZE AND REPLACE IT WITH 54 MM CUP TO COMPLETE THE SURGERY. NO FURTHER COMPLICATIONS WERE NOTED. ATTEMPTS ARE MADE BUT NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355099 G7 BONEMASTER LTD ACET SHL 52E PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6223488

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention