BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 36MM D

    MDR report key: 7303417 · Received February 28, 2018

    Report

    Report Number
    0001825034-2018-00756
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Report Date
    June 4, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 110010243, G7 OSSEOTI 3 HOLE SHELL 50MM D, 6190053. (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.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED DAMAGE TO THE LINER FROM ATTEMPTED IMPLANTATION AND REMOVAL. RETURNED LINER ALSO SHOWS DAMAGE ON THE SCALLOPS AND CIRCULAR INDENTIONS ON THE OUTER RADIUS THAT INDICATE A SCREW CAME IN CONTACT WITH THE LINER DURING ATTEMPTS AT IMPACTION. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER WAS PUT INTO THE SHELL BUT COULD NOT BE FIXED INTO THE SHELL. THE SURGERY WAS FINISHED WITH A BACKUP LINER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147531 G7 NEUTRAL E1 LINER 36MM D PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6176908

    Patients

    Seq Age Sex Outcome Treatment
    1