BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 28MM B

    MDR report key: 7302157 · Received February 28, 2018

    Report

    Report Number
    0001825034-2018-01219
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Report Date
    October 16, 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 · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE DEVICES WERE ASSEMBLED UPON RECEIPT. THE RIM OF BOTH THE LINER AND SHELL ARE SCRATCHED. A GOUGE IN THE OUTER RADIUS OF THE LINER COULD BE OBSERVED THROUGH THE HOLE AT THE APEX OF THE SHELL. THE LINER APPEARS TO BE FULLY SEATED WITHIN THE SHELL. ADDITIONAL INFORMATION RECEIVED DOES NOT CHANGE THE PREVIOUSLY SUBMITTED INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010261, G7 OSSEOTI MULTI HOLE CUP, 6190009, 010000836, G7 NEUTRAL E1 LINER 28MM B, 6014223. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01218, 0001825034 - 2018 - 01220.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 TWO LINERS COULD NOT FIT THE ACETABULAR SHELL. THE HOSPITAL HAD TWO OF THE SAME SIZE LINERS; HOWEVER, THE TWO PIECES COULD NOT BE FIXED. THE SURGERY WAS FINISHED WITH BACKUP PRODUCT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145737 G7 NEUTRAL E1 LINER 28MM B PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6170936

    Patients

    Seq Age Sex Outcome Treatment
    1