BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 32MM B

    MDR report key: 12671580 · Received October 21, 2021

    Report

    Report Number
    0001825034-2021-02898
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 29, 2021
    Report Date
    February 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304527003
    PMA / PMN Number
    K121874
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL DEVICES: 010000924-G7 HI-WALL E1 LINER 32MM B-6771723. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02897. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INITIAL HIP ARTHROPLASTY THE SURGEON COULD NOT GET THE FIRST G7 HIGHWALL LINER TO SEAT. SURGEON HAD TO ENSURE THE INTERIOR OF THE SHELL IS DRY AND FREE OF DEBRIS, OVERHANGING SOFT TISSUE WAS REMOVED. SURGEON MANUALLY PLACED THE LINER INTO THE SHELL, ENSURING THE SCALLOPS WERE CORRECTLY ALIGNED WITH THE RECESSED AREAS ON THE SHELL. APPLYING MANUAL PRESSURE TO THE DOME REGION TO PROVISIONALLY SECURE THE LINER IN PLACE BY LIGHTLY ENGAGING THE SCALLOPS. UTILIZING THE APPROPRIATELY SIZED G7 BALL IMPACTOR, PLACED THE TIP OF THE IMPACTOR ON THE DOME OF THE LINER WITH THE HANDLE PERPENDICULAR TO THE FACE OF THE SHELL. AFTER SEVERAL ATTEMPTS, SURGEON OPENED THE SECOND LINER. MULTIPLE ATTEMPTS WITH SAME TECHNIQUE, SURGEON WAS FINALLY ABLE TO GET SECOND LINER TO SEAT. 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
    1575489 G7 HI-WALL E1 LINER 32MM B PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6854139 00880304527003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female SEE H10