BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 LONGEVITY HIGH WALL 40MM F

    MDR report key: 14427980 · Received May 18, 2022

    Report

    Report Number
    0001822565-2022-01451
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024519381
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010265 ¿ G7 SHELL ¿ 65202253. 12-151307 ¿ ECHO STEM ¿ 209510. 010001035 ¿ COCR HEAD ¿ J7181153. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LEFT HIP PROCEDURE, THE LINER WOULD NOT SEAT IN THE CUP. THE SURGEON HIT SO HARD DURING ATTEMPTS TO SEAT THE LINER THAT THE CUP DISLODGED. THE SURGEON HAD TO IMPLANT A LARGER CUP AND LINER AS A RESULT. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. 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
    1710931 G7 LONGEVITY HIGH WALL 40MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65233858 00889024519381

    Patients

    Seq Age Sex Outcome Treatment
    1 Male