BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 36MM G

    MDR report key: 18731593 · Received February 19, 2024

    Report

    Report Number
    0001822565-2024-00592
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    March 7, 2023
    Report Date
    April 17, 2024
    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
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). D10: CAT# 00877703603 LOT# 2963426 BIOLOX® OPTION, HEAD, L, ø 36/+3.5, TAPER 12/14 G2: FOREIGN ¿ NEW ZEALAND. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE REVIEWED AND IDENTIFIED THE FOLLOWING: THE PATIENT UNDERWENT AN INITIAL LEFT THA. THE PATIENT WAS REVISED ON ONE YEAR LATER DUE TO DISLOCATION AND THE HEAD WAS EXCHANGED. A SECOND REVISION OCCURRED ANOTHER YEAR LATER DUE TO A SECOND DISLOCATION, WHERE THE HEAD AND LINER WERE EXCHANGED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS. 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 PATIENT WAS REVISED APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO A DISLOCATION. THE HEAD WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386857 G7 HI-WALL E1 LINER 36MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6854147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE.