BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 42MM E

    MDR report key: 7644853 · Received June 28, 2018

    Report

    Report Number
    0001825034-2018-04311
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    June 27, 2017
    Report Date
    June 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: EP-200148 ACT ARTIC E1 HIP BRG 28X42MM 091490, 110010244 G7 OSSEOTI 3 HOLE SHELL 52MM E 3836266, UNK 28 MM HEAD, UNKNOWN STEM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. VISUAL INSPECTION FOUND THE DUAL MOBILITY LINER TO BE HEAVILY DAMAGED. THE INNER RADIUS IS GOUGED. A HOLE HAS BEEN CREATED NEAR THE APEX OF THE RADIUS. THE RIM IS ALSO HEAVILY DEFORMED AND IT WAS REPORTED THIS OCCURRED DURING REMOVAL OF THE LINER. NO DIMENSIONAL ANALYSIS WILL BE PERFORMED DUE TO THE CONDITION OF THE LINER.FEMORAL HEAD WAS RETURNED WITH THE POLY BEARING AND DUAL MOBILITY LINER. REVIEW OF PICTURE OF THE FEMORAL HEAD WITH THE DEVELOPMENT ENGINEER CONFIRMED THE DEVICE IS NOT ZIMMER BIOMET. ZIMMER-BIOMET HAS NOT CONFIRMED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. HOWEVER, IT CANNOT BE CONFIRMED THAT THIS INCOMPATIBILITY HAS ANY DEFINITIVE RELATIONSHIP TO THE REPORTED EVENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0001822565-2017-05225.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISASSOCIATION. THE PATIENT PRESENTED TO SURGERY WITH A DISLOCATED DUAL MOBILITY HIP PROSTHESIS. IT WAS FOUND THAT THE POLY BEARING HAD DISASSOCIATED WITH THE FEMORAL HEAD AND THE SURGEON ELECTED TO REMOVE THE DUAL MOBILITY LINER FROM THE SHELL TO REPLACE IT WITH A CONSTRAINED LINER TO PREVENT FURTHER DISLOCATIONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488268 G7 DUAL MOBILITY LINER 42MM E HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 202470

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention| S