BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 6299064 · Received February 2, 2017

    Report

    Report Number
    0001822565-2017-00438
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    October 21, 2016
    Report Date
    April 28, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED 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.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. MATTHIEU OLLIVIER, ET AL. ¿USE OF POROUS TANTALUM COMPONENTS IN PAPROSKY TWO AND THREE ACETABULAR REVISION. A MINIMUM FIVE-YEAR FOLLOW-UP OF FIFTY ONE HIPS.¿ 10.1007/S00264-016-3312-2.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT 2 PATIENTS UNDERWENT PROCEDURES TO REALIGN ACETABULAR LINERS DUE TO INSTABILITY. NO COMPONENTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE AND PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78816 UNKNOWN HIP PROSTHESIS, HIP JDI ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention