BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 6MM PLUG PULLER

    MDR report key: 15068150 · Received July 20, 2022

    Report

    Report Number
    0001825034-2022-01691
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    May 2, 2022
    Report Date
    September 29, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDX
    UDI-DI
    008030400556
    PMA / PMN Number
    K031280
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN-UNKNOWN ULTRA DRIVE-UNKNOWN. THREE (3) TOOL IDS WERE PROVIDED BY THE SALES REP; OF THESE, ONLY ONE (1) WAS REPORTED TO HAVE FRACTURED. IT IS UNKNOWN WHICH EXACT TOOL ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 423868, LOT#: 000950. MANUFACTURE DATE: OCT 1, 2020. STERILE EXPIRY DATE: OCT 1, 2030. UDI: (B)(4). 510K: K031280. PRO CODE: JDX. OR ITEM#: 423868 LOT#: 333790. MANUFACTURE DATE: OCT 29, 2021. STERILE EXPIRY DATE: OCT 29, 2031. UDI: (B)(4). 510K: K031280 PRO CODE: JDX. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS AND RADIOGRAPHS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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

    IT WAS REPORTED THAT THE BIOMET ULTRA DRIVE PLUG PULLER END PIECE FRACTURED AND BECAME LODGED WITHIN THE BONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A GIRDLESTONE PROCEDURE WITH EXPLANATION OF COMPETITOR HIP HEMIARTHROPLASTY COMPONENTS DUE TO A FALL, DISLOCATION, AND UNDERLYING INFECTION, APPROXIMATELY 1-YEAR POST IMPLANTATION. DURING THE PROCEDURE, AN ULTRASONIC DEVICE WAS USED TO LOOSEN AS MUCH OF THE CEMENT AS POSSIBLE WHICH WAS EXTRACTED IN PIECES. THE POSTERIOR CORTEX OF THE FEMUR WAS PERFORATED DURING CEMENT EXTRACTION. A PIECE OF THE CEMENT EXTRACTION DEVICE DID BREAK AND WAS LODGED IN THE FEMUR. THIS PIECE OF METAL COULD NOT BE EXTRACTED AS IT WOULD CAUSE TOO MUCH DAMAGE TO THE BONE. 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
    401586 ULTRA DRIVE 6MM PLUG PULLER BONE CEMENT JDX ZIMMER BIOMET, INC. N/A 850700 008030400556

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10 NARRATIVE.