BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 10 DEG ARCOMXL LINER 36MM E

    MDR report key: 7149529 · Received December 27, 2017

    Report

    Report Number
    0001825034-2017-11256
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    November 28, 2017
    Report Date
    December 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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: 110017103, G7 FINNED 3 HOLE SHELL 52E, 6081888. THE 010000779, G7 10 DEG ARCOMXL LINER 36 MM E, 6076291. 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: 0001825034-2017-11255, 0001825034-2017-11257.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL LEFT HIP PROCEDURE, THE LINER WOULD NOT SEAT INTO THE SHELL. AFTER THE CUP WAS CLEANED AND INSPECTED, THE SURGEON TRIED TO SEAT THE LINER AGAIN; HOWEVER, THE LINER STILL DID NOT LOCK IN. THE SURGEON OPENED A NEW LINER AND TRIED TO SEAT THE LINER AGAIN, AND THE PELVIS FRACTURED WHILE TRYING TO GET THE LINER TO SEAT. THE PROCEDURE WAS COMPLETED WITH A LARGER SHELL AND CEMENTED LINER. THE PROCEDURE WAS DELAYED FOR 45 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928613 G7 10 DEG ARCOMXL LINER 36MM E PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6065016

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R