BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FINNED BM 3 HOLE SHELL 48C

    MDR report key: 7798983 · Received August 20, 2018

    Report

    Report Number
    0001825034-2018-08368
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    September 2, 2016
    Report Date
    August 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE US, HOWEVER IT WAS DETERMINED TO BE SIMILAR TO DEVICES CLEARED UNDER K121874. 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). ADDITIONAL MDRS WERE FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03904 / 03905). (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 NEUTRAL E1 LINER 32MM C CAT: 010000847 LOT: 3820026, G7 HIGH WALL E1 LINER 32MM C CAT: 010000925 LOT: 3820056. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION FOUND SCRATCHING ON THE RIM AND INNER RADIUS OF THE SHELL. NO DAMAGE TO THE LOCKING GROOVE WAS OBSERVED. THE POROUS COATING ON THE OUTER RADIUS IS FREE OF FOREIGN DEBRIS AND DISCOLORATION. NO DIMENSIONAL ANALYSIS WILL BE CONDUCTED AT THIS TIME. 100% AUTOMATED MEASURING AT THE TIME OF PRODUCTION SHOWS THE DEVICE(S) MET ALL DIMENSIONAL SPECIFICATIONS. DEVICE HISTORY RECORD 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

    DURING A RIGHT HIP REVISION OF COMPETITOR PRODUCT, THE SURGEON HAD DIFFICULTLY INSERTING THE LINER INTO THE SHELL. A NEW LINER OF THE SAME SIZE WAS ATTEMPTED TO BE IMPACTED TO THE SHELL; HOWEVER, THE LINER WOULD NOT SEAT. THE PATIENT'S PELVIS FRACTURED AFTER MULTIPLE IMPACTIONS. A THIRD LINER WAS CEMENTED IN TO THE SHELL TO COMPLETE THE PROCEDURE. THERE WAS A1-2 HOUR DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638962 G7 FINNED BM 3 HOLE SHELL 48C HIP, PROSTHESIS JDI ZIMMER BIOMET, INC. 3585617

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R