BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 36MM H

    MDR report key: 7446651 · Received April 20, 2018

    Report

    Report Number
    0001825034-2018-02347
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 21, 2018
    Report Date
    June 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: ITEM# 010000938 G7 HI-WALL E1 LINER 36MM H LOT#3940036; 010000668 G7 POUROUS PLASMA SPRAY LTD ACETABULAR SHELL 62H LOT#3831312; 00625006525 BONE SCR 6.5X25 SELF-TAP LOT#63953723; 00625006520 BONE SCR 6.5X20 SELF-TAP LOT#63347329. MULTIPLE MDR'S FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:MULTIPLE MDR'S FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MULTIPLE MDR'S FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02346; 0001825034-2018-02344.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED AS VISUAL INSPECTION NOTED THE LINERS EXHIBIT DAMAGE NEAR THE SCALLOPS AND ON THE FACE OF THE RIM. ALSO NOTED WAS SMALL DAMAGE TO THE LOCKING FEATURE OF THE LINERS WHICH IS CONSISTENT FROM THE LINER IMPACTION. DAMAGE TO THE SCREW HOLE LIKELY OCCURRED DURING SCREW INSERTION. 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 · 1

    IT WAS REPORTED THAT DURING REVISION SURGERY, SURGEON WAS UNABLE TO SEAT LINER IN SHELL. SURGEON ATTEMPTED 2 DIFFERENT LINERS WITH NO SUCCESS. SURGEON USED DIFFERENT LINER/SHELL TO COMPLETE SURGERY. NO ADVERSE EVENT NOTED TO PATIENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289534 G7 HI-WALL E1 LINER 36MM H HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 3929937

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR