BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 32MM B

    MDR report key: 12671557 · Received October 21, 2021

    Report

    Report Number
    0001825034-2021-02897
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ONE G7 HI-WALL E1 LINER 32MM B ITEM# 010000924 LOT# 6771723 APPROXIMATE AGE OF 1 YEAR WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE DEVICE HAS INDENTATIONS ON THE OUTER RADIUS ALONG WITH INDENTATIONS ON THE LOCKING FEATURE. THERE IS NO OTHER VISIBLE DAMAGE TO THE DEVICE. THE DEVICE WAS FOUND TO BE CONFORMING TO PRINT SPECIFICATIONS DURING MANUFACTURING. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE COULD NOT 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 ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: 010000924-G7 HI-WALL E1 LINER 32MM B-6854139. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -02898. 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.

    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
    1574796 G7 HI-WALL E1 LINER 32MM B PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6771723 00880304527003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female