BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 28MM A

    MDR report key: 8585723 · Received May 7, 2019

    Report

    Report Number
    0001825034-2019-02038
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    March 30, 2019
    Report Date
    August 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI# (B)(4). REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS AND RADIOGRAPHS PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SUPERIOR DISLOCATION OF THE RIGHT FEMORAL HEAD FROM A RIGHT TOTAL HIP ARTHROPLASTY. POSSIBLE AVN WITH BONY COLLAPSE OF THE LEFT FEMORAL HEAD. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#110010260 LOT 6278320 BIOMET G7 SHELL 44MM, CAT#8114-01-10 LOT 61452413 ZIMMER CPT STEM HO SIZE 1, CAT#8018-28-14 LOT 64157142 ZIMMER VERSYS HEAD 28MM+7NECK. FOREIGN SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, IT WAS NOTED THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379457 G7 NEUTRAL E1 LINER 28MM A PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 3645890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R