BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM D

    MDR report key: 7335115 · Received March 13, 2018

    Report

    Report Number
    0001825034-2018-01696
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    July 11, 2014
    Report Date
    May 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS AND MEDICAL RECORDS. RADIOGRAPHS PERFORMED (B)(6), 2014 REVEALED PERIPROSTHETIC LUCENCY SURROUNDS THE FEMORAL SYSTEM, SUSPICIOUS FOR LOOSENING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 010000662, G7 PPS LTD ACET SHELL 50D, 3214442; UNKNOWN, DEPUY HEAD, 7862512; UNKNOWN, DEPUY STEM, 5227389. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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 - 01695. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A TWO STAGE REVISION PROCEDURE DUE TO INFECTION TWO MONTHS POST-IMPLANTATION. THE CUP AND LINER WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177174 G7 NEUTRAL E1 LINER 36MM D PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 3309833

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R