BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E NEUTRAL LNR 36MM F

    MDR report key: 12693681 · Received October 25, 2021

    Report

    Report Number
    0001822565-2021-03103
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    October 2, 2021
    Report Date
    February 2, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K190660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS ITS UNAVAILABLE PER HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART # 650-0661/DELTA CERAMIC FEM HD/ LOT # 3050950. PART #010000664/ G7 PPS LTD ACET SHELL / LOT # 6549398. PART #51-103110/ TPRLC 133 T1 PPS / LOT # 6892440.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT HIP REVISION SURGERY APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO INSTABILITY AND DISLOCATION. THE LINER AND HEAD WERE REMOVED AND REPLACED WITH DUEL MOBILITY. 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
    1585733 G7 VIT E NEUTRAL LNR 36MM F PROSTHESIS HIP KWZ ZIMMER BIOMET, INC. NI 65051774

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE