BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 32MM C

    MDR report key: 11618816 · Received April 6, 2021

    Report

    Report Number
    0001825034-2021-00979
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 24, 2021
    Report Date
    July 28, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. A G7 NEUTRAL E1 LINER WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE LINER TO BE IN DECENT OVERALL CONDITION. INDENTATIONS AND SCRATCHING WERE OBSERVED ON THE RIM OF THE LINER. THE BARB AND SCALLOPS ARE UNDAMAGED. A CIRCULAR INDENTATION IS PRESENT ON THE OUTER RADIUS IN 1 LOCATION WITH LIGHT SCRAPING NEAR IT. THE REMAINDER OF THE OUTER RADIUS IS UNDAMAGED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 REPORT 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). CONCOMITANT MEDICAL DEVICES: 110017330 6892575 G7 BISPHERICAL SHELL 48C. FOREIGN COUNTRY: (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 THE PATIENT UNDERWENT A HIP PROCEDURE. DURING THE PROCEDURE, THE LINER WOULD NOT SEAT INTO THE CUP. THE SIZE 48 CUP WAS REMOVED AND REPLACED WITH A SIZE 50 CUP. SALES REP INDICATES NO ADDITIONAL INFORMATION IS AVAILABLE. 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
    521301 G7 NEUTRAL E1 LINER 32MM C PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6495751

    Patients

    Seq Age Sex Outcome Treatment
    1