BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 36MM E

    MDR report key: 7564850 · Received June 4, 2018

    Report

    Report Number
    0001825034-2018-03736
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 10, 2018
    Report Date
    February 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION FOUND MULTIPLE FORMS OF DAMAGE TO THE LINER. THE BARB HAS BEEN ROUGHENED TO THE EXTENT THAT 2 STRANDS OF POLY MATERIAL PROTRUDE FROM THE LINER. THE LINER IS ALSO SCRATCHED NEAR ONE OF THE POLY STRANDS. THE ORIENTATION FEATURE OF THE SHELL HAS BEEN INDENTED INTO THE LINER'S APEX. THE SIDEWALL IS SCUFFED BETWEEN THE SCALLOPS. VARYING DEGREES OF SCUFFING WAS FOUND BETWEEN THE SCALLOPS AROUND THE CIRCUMFERENCE OF THE LINER. NO DIMENSIONAL ANALYSIS WILL BE PERFORMED DUE TO ATTEMPTS TO IMPLANT AND REMOVE THE LINER. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT 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). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 110010244, CUP, LOT # 6250529, ITEM # 010000935, LINER, LOT # 6183580. (B)(6). MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03735, 0001825034-2018-03737.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE LINERS WOULD NOT SEAT PROPERLY INTO THE CUP. SURGERY WAS FINISHED WITH BACKUP LINER AND CUP. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407799 G7 NEUTRAL E1 LINER 36MM E HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 6238031

    Patients

    Seq Age Sex Outcome Treatment
    1