BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 36MM G

    MDR report key: 11203463 · Received January 20, 2021

    Report

    Report Number
    0001825034-2021-00080
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    January 11, 2021
    Report Date
    April 5, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; D9; G3; H2; H3; H4; H6 COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AGAINST THE REPORTED EVENT. UPON VISUAL INSPECTION THE DEVICE DOES NOT SHOW ANY DAMAGE TO THE OUTSIDE RADIUS OF THE DEVICE. THE LOCKING FEATURE HAS INDENTATIONS IN MULTIPLE LOCATIONS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 010000666 G7 PPS LTD ACET SHELL 58G LOT#: 6861893 CATALOG#: 010000937 G7 HI-WALL E1 LINER 36MM G LOT#: 6854147 REPORT SOURCE: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE, AFTER MANY ATTEMPTS, THE LINER WOULD NOT LOCK INTO THE SHELL. AN ALTERNATE LINER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. 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
    100701 G7 HI-WALL E1 LINER 36MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6724563

    Patients

    Seq Age Sex Outcome Treatment
    1